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75 Study Matches

Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy (MILES)

The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.
Call 214-648-5005
studyfinder@utsouthwestern.edu
John Bird
108478
All
2 Years to 17 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02223182
STU 092014-046
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Eligibility criteria for study enrollment:
Inclusion Criteria:

• Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed assent form (IAF) for subjects ≥7 years, or as per local or country specific guidelines or regulations.
• Male or female subjects 2 to 17 years old at Visit 1.
• Documented medical history or physician-confirmed diagnosis of IgE-mediated CMA with systemic symptoms related to ingestion of milk or dairy products.
• Subjects currently following a strict cow's milk-free diet, with no consumption of dairy or baked milk products.
• Cow's milk-specific IgE level at screening ≥10 kU/L
• Positive Skin Prick Test (SPT) to cow's milk with a largest wheal diameter ≥6 mm.
• Positive DBPCFC at screening with an eliciting dose ≤300 mg cow's milk proteins (approximately ≤9.4 mL of cow's milk).
• Negative urine pregnancy test for female subjects of childbearing potential. Female subjects of childbearing potential must agree and commit to use effective medical methods of contraception for the entire duration of their participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
• Ability to perform spirometry procedures in accordance with the American Thoracic Society guidelines (2005) for subjects ≥6 years old. Ability to perform peak expiratory flow (PEF) measurements for subjects ≥5 years old. Subjects <8 years of age who have documented inability to adequately perform spirometry can perform only the PEF evaluation. Subjects <5 years of age may be enrolled if they had no clinical features of moderate or severe persistent asthma severity (as defined by the 2007 National Heart, Lung, and Blood Institute [NHLBI] Guidelines) within 1 year before Visit 1.
• Subjects and/or parents/guardians willing to comply with all study requirements during participation in the study.
Exclusion Criteria:

• History of severe anaphylaxis to cow's milk resulting in hypotension, hypoxia or neurological compromise (collapse, loss of consciousness or incontinence) or requiring mechanical ventilation.
• Pregnancy or lactation.
• Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value at Visit 1 for subjects ≥6 years and able to perform the spirometry, or PEF <80% of predicted value at Visit 1 for subjects performing only the PEF measurements.
• Any clinical features of moderate or severe persistent asthma severity (as defined by the 2007 NHLBI guidelines) and high daily doses of inhaled corticosteroids.
• Known allergy to the Viaskin patch materials or excipients, or to any of the components of the food challenge formulas other than the cow's milk proteins.
• Allergy or known history of reaction to Tegaderm® medical dressing with no possibility to use an alternative adhesive dressing authorized by the sponsor in replacement.
• Subjects having objective symptoms to the placebo formula leading to stopping the challenge during the screening DBPCFC.
• Severe reaction during the screening DBPCFC defined as need for intubation, and/or hypotension persisting after epinephrine administration, and/or the need for >2 doses of epinephrine.
• Symptomatic allergy to pollens with symptoms during the pollen season that might interfere with the symptoms observed during the DBPCFC, if the DBPCFC is performed during the pollen season. Screening of such subjects should be made out of the pollen season.
• Inability to discontinue short-acting antihistamines for 3 days or long-acting antihistamines for 5 to 7 days (depending on the half-life) before the DBPCFC.
• Use of systemic long-acting corticosteroids within 12 weeks before Visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks before Visit 1 or use of systemic long-acting or short-acting corticosteroids during screening (unless used to treat symptoms triggered by the DBPCFC or triggered by accidental allergen consumption; in the latter case DBPCFC must then be scheduled after a minimum of 7 wash-out days).
• Subjects with asthma conditions meeting 1 or several criteria below:
• Uncontrolled persistent asthma (as defined by the 2007 NHLBI guidelines) or subject being treated with a combination therapy of medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2-agonist. Intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are permitted.
• At least 2 systemic corticosteroid courses for asthma within 1 year before Visit 1 or 1 oral corticosteroid course for asthma within 3 months before Visit 1, or during screening (unless used to treat symptoms triggered by the DBPCFC).
• Prior intubation/mechanical ventilation due to asthma within 2 years before Visit 1, or during screening.
• Upper respiratory infection or gastroenteritis within 7 days of DBPCFC (DBPCFC must then be rescheduled at least 7 days after resolution of these conditions).
• Any history of milk immunotherapy (eg, oral immunotherapy, sublingual immunotherapy or specific oral tolerance induction).
• Prior history of any other food allergen immunotherapy (eg, oral immunotherapy, sublingual immunotherapy or specific oral tolerance induction) within 5 years before Visit 1.
• Subjects currently under aeroallergen immunotherapy and unwilling or unable to discontinue at the time of Visit 1. Aeroallergen Immunotherapy must be discontinued at the time of Visit 1.
• Use of any anti-IgE drug (eg, omalizumab), any immunomodulatory therapy, or any biological agent therapy (eg, anti-tumor necrosis factor drugs) within 1 year before Visit 1, or during screening.
• Generalized dermatologic diseases (eg, severe atopic dermatitis, uncontrolled generalized eczema, icthyosis vulgaris) with no intact zones to apply the Viaskin patch, or urticarial and mast cells disorders such as chronic idiopathic urticaria.
• Subject and/or subject's parents/guardians with obvious excessive anxiety and unlikely to cope with the conditions of a food challenge.
• Past or current disease, including but not limited to active eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled disease (hypertension, diabetes, psychiatric disorder, cardiac disease), or other disorders (eg, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease or blood disorder) which in the opinion of the Investigator or the sponsor may affect the subject's participation in the study or place the subject at increased risk.
• Subjects and/or parents/guardians unable to use the epinephrine auto-injector properly in spite of being adequately trained.
• Contraindicated condition for the use of epinephrine.
• Use of any investigational drug or device, or participation in another interventional clinical study within 3 months before Visit 1.
• Subjects receiving beta-blockers or Angiotensin converting-enzyme (ACE) inhibitors.
• Subjects unable to follow the protocol requirements.
Biological: Viaskin Milk 150 mcg, Biological: Viaskin Milk 300 mcg, Biological: Viaskin Milk 500 mcg, Biological: Viaskin Placebo
Food Allergy
Milk Allergy,, Viaskin Milk,, Specific Immunotherapy,, Epicutaneous ImmunoTherapy (EPIT), IgE-Mediated Cow's Milk Allergy
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TransMedics (OCS) Liver Trial: Preserving and Assessing Donor Livers for Transplantation (Liver PROTECT)

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Malcolm MacConmara
157434
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02522871
STU 092015-076
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Inclusion Criteria:

• Registered male or female primary Liver transplant candidate
• Age ≥18 years old
• Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria:

• Acute, fulminant liver failure
• Prior solid organ or bone marrow transplant
• Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl for >2 weeks and/or requiring hemodialysis
• Multi-organ transplant
• Ventilator dependent
• Dependent on > 1 IV inotrope to maintain hemodynamics
Device: OCS™ Liver System, Other: Control
Liver Transplantation, Liver Preservation for Transplant
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Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients With Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery

This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02595424
STU 122015-043
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Inclusion Criteria:

• Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of gastrointestinal (GI) origin; primary tumors arising from the lung, gynecologic organs or prostate are not permitted
• Patients must have pathologically/histologically confirmed tumor of non-small cell histology
• Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields
• Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained within 4 weeks prior to randomization and must be acquired by multiphasic computed tomography (CT) or contrast magnetic resonance imaging (MRI)
• NOTE: positron emission tomography (PET)-CT scans are allowed provided the CT portion of the exam is equivalent to a diagnostic CT scan and includes both oral and IV contrast
• Patients may not have had any prior systemic treatment for this malignancy (for example chemotherapy or somatostatin analogues); prior palliative radiation is permitted but radiated lesions may not be used for measurement
• Patients may not have received any of the protocol agents within 5 years prior to randomization
• Any prior surgeries must have been completed at least 4 weeks prior to randomization
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients may not be receiving any other investigational agents while on study treatment
• Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed
• Leukocytes >= 3,000/mm^3
• Absolute neutrophil count >= 1,500/mm^3
• Hemoglobin >= 9 g/dL
• Platelets >= 100,000/mm^3
• Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN or (=< 5 X institutional ULN if the patient has liver metastases)
• Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min
• NOTE: creatinine clearance must be calculated using the Cockcroft-Gault equation
• Patients must have a life expectancy of >= 12 weeks as determined clinically by the treating physician
• Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible
• Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency will be excluded
• Patients must NOT have active or uncontrolled infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia or a serious psychiatric illness/social situation that would limit compliance with study requirements
• Patients with impaired decision making capacity may participate in the study if a legal authorized representative is available to consent
• Patients must NOT have a history of allergic reactions attributed to compounds of similar chemical or biochemical composition to cisplatin, carboplatin, etoposide, temozolomide or capecitabine
• Patients must NOT have absorption issues that would limit the ability to absorb study agents
• Patients with a history of the following within =< 12 months of study entry are not eligible:
• Arterial thromboembolic events
• Unstable angina
• Myocardial Infarction
• Patients with symptomatic peripheral vascular disease are not eligible
• Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
• Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR
• Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
• Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years
• Women must not be pregnant or breast-feeding
• All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
• A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
• Patients must be able to swallow pills
• Patients must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for the treatment and the protocol
• Patients who are known to have human immunodeficiency virus (HIV) or are on combination antiretroviral therapy are ineligible
Drug: Capecitabine, Drug: Carboplatin, Drug: Cisplatin, Drug: Etoposide, Other: Laboratory Biomarker Analysis, Drug: Temozolomide
Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma
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Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

The investigators hypothesize that this combination regimen of irinotecan plus ramucirumab administered as second line treatment will be tolerated and lead to improved outcomes similar to paclitaxel plus ramucirumab in patients with advanced gastric and gastro-esophageal junction (GEJ) cancers. This study proposes a phase II clinical trial with irinotecan plus ramucirumab for treatment of patients with metastatic gastric and GEJ adenocarcinoma who have progressed after first line chemotherapy. To the knowledge of the investigators, this regimen has not been previously administered to this patient population, so safety and tolerability will be monitored and reported.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Aravind Sanjeevaiah
171563
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03141034
STU 122017-031
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Inclusion Criteria:

• Histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma that is metastatic or locally advanced and unresectable.
• Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan (or MRI at the discretion of the principal investigator (PI)), as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
• Experienced documented objective radiographic or clinical disease progression during first-line therapy or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) or taxane (docetaxel) for unresectable or metastatic disease.
• At least 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Normal bone marrow and organ function as defined below:
• Absolute neutrophil count (ANC) ≥ 1,500/µL
• Hemoglobin ≥ 9.0 g/dL (5.58 mmol/L)
• Platelets ≥ 100,000/µL
• Total bilirubin ≤ 1.5 mg/dL (25.65 µmol/L)
• AST(SGOT)/ALT(SGPT) ≤ 3.0 x institutional upper limit of normal (IULN) (or ≤ 5.0 x IULN in the setting of liver metastases)
• Creatinine ≤ 1.5 x IULN OR creatinine clearance ≥ 40 mL/min/1.73 m2 for patients with creatinine levels > 1.5 x IULN (that is, if serum creatinine is > 1.5 x IULN, a 24-hour urine collection to calculate creatinine clearance must be performed)
• Urinary protein ≤ 1+ on dipstick or routine urinalysis (UA); if dipstick or routine UA is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours
• Adequate coagulation function as defined by INR ≤ 1.5 and PTT ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy.
• All clinically significant toxic effects (except peripheral neuropathy) of prior locoregional therapy, surgery, or other anticancer therapy have resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) grade 1.
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Women of childbearing potential must have a negative serum pregnancy test within 7 days of study entry.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:

• Squamous cell or undifferentiated gastric cancer.
• Received any chemotherapy (including irinotecan) other than platinum and fluoropyrimidine with or without anthracycline or taxane for advanced gastric or GEJ adenocarcinoma.
• Received previous systemic chemotherapy with a cumulative dose of > 900 mg/m^2 of epirubicin or > 400 mg/m^2 of doxorubicin.
• Received any previously systemic therapy (including investigational agents) targeting VEGF or the VEGFR signaling pathways. Other previous targeted therapies are permitted if stopped at least 28 days prior to start of treatment.
• A history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix or other solid tumors treated curatively and without evidence of recurrence.
• Currently receiving any other investigational agents.
• History or evidence of known brain metastases or carcinomatous meningitis. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibody treatment, any components used in the ramucirumab DP preparation, irinotecan, or other agents used in the study.
• Any grade 3-4 GI bleeding within 3 months prior to enrollment.
• History of gastrointestinal perforation and/or fistulae within 6 months prior to enrollment.
• History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port of catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to enrollment.
• History of any arterial thromboembolic event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina within 6 months prior to enrollment.
• Diagnosis of symptomatic congestive heart failure (NYHA II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
• Uncontrolled or poorly controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management.
• Presence of serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
• Major surgery within 28 days prior to first dose of protocol therapy.
• Minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy.
• Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
• The patient has elective or planned major surgery to be performed during the course of the clinical trial.
• Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
• Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (i.e. ascites from cirrhosis requiring diuretics or paracentesis).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, metabolic disorders or other nonmalignant organ or systemic disease or secondary effects of cancer that induce a high medical risk and make assessment of survival uncertain, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding.
• Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with ramucirumab and irinotecan. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Drug: Irinotecan, Drug: Ramucirumab, Genetic: Blood for angiome profiling, Genetic: Blood for cfDNA
Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
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A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects must not have received prior systemic therapy for advanced HCC in keeping with the first-line setting of this study.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03519997
STU 102017-015
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Inclusion Criteria:

• Patient must have a histologically confirmed diagnosis hepatocellular carcinoma; known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC will be excluded
• Locally advanced or metastatic disease
• Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
• Measurable disease, as defined as lesions that can accurately be measured in at least one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography).
• Child-Pugh Score A
• Age ≥ 18 years
• ECOG Performance score of 0-1
• Life expectancy greater than 6 months
• Following baseline laboratory values: 1. Total bilirubin ≤ 2.0 mg/ml 2. INR ≤ 1.7 3. Hgb ≥ 8.5 g/dl 4. AST, ALT ≤5 times ULN 5. Platelet count ≥ 50,000/mm3 6. Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min 7. Albumin ≥ 2.5 g/dl 8. Absolute neutrophil ≥ 1,500 cells/mm3
• Male and female subjects of child bearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
• Women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
• Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows: HBV-HCC: Controlled (treated) hepatitis B subjects will be allowed if they meet the following criteria: Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study treatment. Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis. HCV-HCC: active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study. In addition, subjects with successful HCV treatment are allowed as long as there are ≥4 weeks between completion of HCV therapy and start of study drug. Successful HCV treatment definition: SVR12.
•Prior therapy is allowed provided the following are met: at least 4 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation. Provided target lesion has increased in size by 25% or more or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible 1 week after treatment as long as the target lesion is not the treated lesion.
Exclusion Criteria:

• Prior liver transplant;
• Patient who has received previous systemic therapy for HCC;
• Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
• History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screening;
• History of documented congestive heart failure (New York Heart Association functional classification III-IV);
• Documented cardiomyopathy;
• Patient has a left ventricular ejection fraction <40% as determined by MUGA scan or ECHO (MUGA and ECHO are not required prior to enrollment);
• Known human immunodeficiency virus (HIV) positive (testing not required);
• History of thromboembolic events (including both pulmonary embolism and deep venous thrombus but not including tumor thrombus) within the last 6 months;
• Hypersensitivity to IV contrast; not suitable for pre-medication;
• Active or fungal infections requiring systemic treatment within 7 days prior to screening;
• Known history of, or any evidence of, interstitial lung disease or active non-infectious pneumonitis;
• Evidence of poorly controlled hypertension which is defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management;
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication;
• Active, known, or suspected autoimmune disease with the following exceptions i) Subjects with vitiligo, type I diabetes mellitus, resolved childhood asthma or atopy are permitted to enroll; ii) Subjects with suspected autoimmune thyroid disorders may be enrolled if they are currently euthyroid or with residual hypothyroidism requiring only hormone replacement. iii) Subjects with psoriasis requiring systemic therapy must be excluded from enrollment
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the study or compromise compliance with the protocol (e.g. chronic pancreatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.);
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the study or compromise compliance with the protocol (e.g. chronic pancreatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.);
• Known history of active bacillus tuberculosis;
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses >10 mg/day prednisone equivalents are permitted in the absence of autoimmune disease;
• Patient who has received radiotherapy ≤ 4 weeks prior to study entry. Palliative radiotherapy for symptomatic control is acceptable (if completed at least 2 weeks prior to study drug administration and no additional radiotherapy for the same lesion is planned);
• Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery);
• Clinically apparent ascites on physical examination, ascites present on imaging studies is allowed;
• Patient has a known hypersensitivity to any of the excipients of bavituximab or pembrolizumab or monoclonal antibody;
• Active gastrointestinal bleeding within previous 2 months;
• History of any condition requiring anti-platelet therapy (aspirin >300 mg/day, clopidogrel >75 mg/day);
• Prisoners or subjects who are involuntarily incarcerated;
• Symptomatic or clinically active brain metastases;
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test;
• Prior immunotherapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents;
• Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection (anti-HCV Ab(+) and detectable HCV RNA) at study entry.
Drug: Pembrolizumab, Drug: Bavituximab
Hepatocellular Carcinoma
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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
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studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03439254
STU 112017-064
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Key inclusion criteria: 1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading Key exclusion criteria: 1. Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding 2. Current or past history of CP score ≥7 points 3. Model for End-stage Liver Disease (MELD) score > 12 4. ALT ≥ 5 X ULN 5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method 6. Hemoglobin A1c (HbA1c) ≥ 9.5 % 7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC) 8. History of liver transplant, or current placement on a liver transplant list
Drug: Obeticholic acid (10 mg), Drug: Obeticholic acid (10 mg to 25 mg), Drug: Placebo
Nonalcoholic Steatohepatitis, Compensated Cirrhosis
Compensated Cirrhosis, Nonalcoholic Steatohepatitis, Fatty Liver Disease, NASH
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A Study of NKTR-262 in Combination With NKTR-214 and With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies (REVEAL)

Patients will receive intratumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration of NKTR-214. After determination of the recommended Phase 2 dose (RP2D) of NKTR-262, NKTR-262 will be combined with NKTR-214 (Cohort A) and with NKTR-214 plus nivolumab (Cohort B). In the Phase 2 dose expansion portion, patients will be treated with NKTR-262 and NKTR-214 (doublet) or NKTR-262 and NKTR-214 plus nivolumab (triplet) in the relapsed/refractory setting and earlier lines of therapy.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
James Brugarolas
80679
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03435640
STU 042018-024
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Inclusion Criteria:

• Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma (HNSCC), or sarcoma.
• Life expectancy > 12 weeks as determined by the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Measurable disease per RECIST 1.1.
• Patients enrolled in Cohorts 1-8, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease.
• Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status.
• Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies. Any liver lesion targeted for injection must not exceed 50 mm at the time of injection.
• Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).
Exclusion Criteria:

• Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s).
• Patients treated with prior interleukin-2 (IL-2).
• Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines.
• Patients who have received systemic interferon (IFN)α within the previous 6 months prior to enrollment to the study.
• Other active malignancy, except non-melanomic skin cancer
• Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
• Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
• Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening. History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
• Unstable angina or myocardial infarction.
• Congestive heart failure (NYHA Class III or IV).
• Uncontrolled clinically significant arrhythmias.
• Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic retinopathy, retinal hemorrhage, macular degeneration).
• Uveal melanoma will be excluded
• Patients with tumor that invade the superior vena cava or other major blood vessels. Additional inclusion and exclusion criteria for specific tumor types will apply.
Drug: NKTR-262, Drug: bempegaldesleukin, Drug: nivolumab
Sarcoma, Melanoma, Colorectal Cancer, Renal Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Merkel Cell Carcinoma
Bempegaldesleukin (NKTR-214), NKTR-262, Nivolumab, Opdivo®, Metastatic, Locally advanced, Relapsed/Refractory, TLR7/8, CD122
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A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (CheckMate 9DX)

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03383458
STU 052018-014
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For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:

• Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
• Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
• Child-Pugh Score 5 or 6
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Any evidence of tumor metastasis or co-existing malignant disease
• Participants previously receiving any prior therapy for HCC, including loco-regional therapies
• Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation Other protocol defined inclusion/exclusion criteria could apply
Biological: Nivolumab, Other: Placebo
Liver Cancer, Hepatocellular Carcinoma
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A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis (FALCON 1)

This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).
Call 214-648-5005
studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03486899
STU-2018-0203
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:

• Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN classification, as assessed by the central reader
• Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
• Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the Screening Period. Vitamin E treatment (>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed.
Exclusion Criteria:

• Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus [HCV] infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
• Current or past history of hepatocellular carcinoma (HCC)
• Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation Other protocol defined inclusion/exclusion criteria could apply
Drug: BMS-986036, Other: Placebo
Nonalcoholic Steatohepatitis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD)
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Phase 1/2 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

This is a Phase 1/2, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
12 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03157128
STU 082018-008
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Key
Inclusion Criteria:
For Phase 1
• Patients with a locally advanced or metastatic solid tumor who:
• have progressed on or are intolerant to standard therapy, or
• no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or
• decline standard therapy
• Prior MKIs with anti-RET activity are allowed.
• A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation.
• Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) ≥ 40% (age < 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment.
• Adequate hematologic, hepatic and renal function.
• Life expectancy of at least 3 months. For Phase 2 As for phase 1 with the following modifications:
• For Cohorts 1 and 3 Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
• Cohorts 1-4: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor. However, a positive germline DNA test for a RET gene mutation is acceptable in the absence of tumor tissue testing for patients with MTC.
• Cohorts 1-4: at least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated.
• Cohort 4: radiographic PD within the previous 14 months. Note: Patients otherwise eligible for cohort 4 who do not demonstrate radiographic PD within the previous 14 months may be enrolled to cohort 5 if a compelling rationale is provided by the investigator and approved by the Sponsor.
• Cohort 5: (up to 150 patients):
• Cohorts 1-4 without measurable disease;
• MTC not meeting the requirements for Cohorts 3 or 4; (a known RET mutation is not required)
• MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval;
• cfDNA positive for a RET gene alteration not known to be present in a tumor sample.
• Cohort 6: Patients who otherwise are eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval. Key Exclusion Criteria (Phase 1 and Phase 2):
• Phase 2 Cohorts 1-4: an additional known oncogenic driver.
• Cohorts 1-5: prior treatment with a selective RET inhibitor Notes: Patients otherwise eligible for Cohorts 1-5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval. Notes: Patients otherwise eligible for Cohorts 1-5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval. Notes: Patients otherwise eligible for Cohorts 1-5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval.
•Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292. In addition, no concurrent investigational anti-cancer therapy is permitted. Note: Potential exception for this exclusion criterion will require a valid scientific justification and approval from the Sponsor.
• Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of LOXO-292.
• Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of LOXO-292, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
• Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery [SRS].
• Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 or prolongation of the QT interval corrected (QTcF) > 470 msec.
• Required treatment with certain strong CYP3A4 inhibitors or inducers and certain prohibited concomitant medications.
Drug: LOXO-292
Non-Small Cell Lung Cancer, Colon Cancer, Medullary Thyroid Cancer, Any Solid Tumor
LOXO-292, KIF5B-RET, M918T, CCDC6-RET, RET-PTC1, NCOA4-RET, RET-PTC, RET-PTC3, RET-PTC4, PRKAR1A-RET, RET-PTC2, GOLGA5-RET, RET-PTC5, ERC1-RET, KTN1-RET, RET-PTC8, HOOK3-RET, PCM1-RET, TRIM24-RET, RET-PTC6, TRIM27-RET, TRIM33-RET, RET-PTC7, AKAP13-RET, FKBP15-RET, SPECC1L-RET, TBL1XR1-RET, BCR-RET, FGRF1OP-RET, RFG8-RET, RET-PTC9, ACBD5-RET, MYH13-RET, CUX1-RET, KIAA1468-RET, FRMD4A-RET, SQSTM1-RET, AFAP1L2-RET, PPFIBP2-RET, EML4-RET, PARD3-RET, G533C, C609F, C609G, C609R, C609S, C609Y, C611F, C611G, C611S, C611Y, C611W, C618F, C618R, C618S, C620F, C620R, C620S, C630R, C630Y, D631Y, C634F, C634G, C634R, C634S, C634W, C634Y, K666E, E768D, L790F, V804L, V804M, A883F, S891A, R912P, CLIP1-RET, Y806C, RET fusion, RET alteration, RET mutation, RET rearrangement, RET translocation, Neoplasms by Site, Neoplasms, Non-Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Respiratory Tract Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Medullary Thyroid Cancer, Papillary Thyroid Cancer, Thyroid Diseases, Thyroid Neoplasms, Cancer of the Thyroid, Cancer of Thyroid, Neoplasms, Thyroid, Thyroid Ademona, Thyroid Cancer, Thyroid Carcinoma, Endocrine System Diseases, Endocrine Gland Neoplasms, Head and Neck Neoplasms, Thoracic Neoplasms, CNS tumor, Primary CNS tumor, Cancer of Colon, Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic, Malignant tumor of Breast, Mammary Cancer, Mammary Carcinoma, Human, Mammary Neoplasm, Human, Neoplasms, Breast, Tumors, Breast, Human Mammary Carcinoma, Malignant Neoplasm of Breast, Breast Carcinoma, Breast Tumors, Cancer of the Breast, Breast Neoplasms, Breast Cancer, RET Inhibitor, MTC, NSCLC
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Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas

This phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back or do not respond to treatment. Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Farrukh Awan
180091
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03038672
STU-2019-0584
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Inclusion Criteria:

• Patients must have a histopathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma that is recurrent or refractory to standard therapy
• For the purpose of this study, aggressive B-cell NHL will be deemed any lymphoma belonging to one of the following groups according to the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms
• For the purposes of stratification, diagnoses are grouped into 2 categories:
• Category A
• Burkitt lymphoma
• Burkitt-like lymphoma with 11q aberration
• High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
• High-grade B-cell lymphoma, not otherwise specified (NOS)
• Category B
• Diffuse large B-cell lymphoma (DLBCL), NOS
• Diffuse large B-cell lymphoma (DLBCL), NOS; germinal center B-cell type
• Diffuse large B-cell lymphoma (DLBCL), NOS; activated B-cell type
• Large B-cell lymphoma with IRF4 rearrangement
• T-cell/histiocyte-rich large B-cell lymphoma
• Primary DLBCL of the central nervous system (CNS)
• Primary cutaneous DLBCL, leg type
• Epstein-Barr virus (EBV)+ DLBCL, NOS
• EBV+ mucocutaneous ulcer
• DLBCL associated with chronic inflammation
• Lymphomatoid granulomatosis
• Primary mediastinal (thymic) large B-cell lymphoma
• Intravascular large B-cell lymphoma
• ALK+ large B-cell lymphoma
• Plasmablastic lymphoma
• Primary effusion lymphoma
• Human herpesvirus (HHV)-8+ DLBCL, NOS
• B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
• Patients must have measurable disease, defined as at least one lesion that is > 15 mm (1.5 cm) in the longest axis on cross-sectional imaging and measurable in two perpendicular dimensions per computed tomography (spiral computed tomography [CT]), positron emission tomography (PET)-CT or magnetic resonance imaging (MRI)
• Patients must have disease that has relapsed after or is refractory to at least 2 lines of standard therapy; the remaining standard treatment options are unlikely to be effective in the opinion of the treating physician, or patient is felt to be ineligible for such therapies or the patient refuses such therapies; patients who have undergone autologous stem cell transplant are eligible as long as they meet all other criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of greater than 12 weeks
• White blood cell (WBC) >= 2000/mm^3 (within 14 days of registration)
• Absolute neutrophil count (ANC) >= 1500/mm^3 (within 14 days of registration)
• Platelet count >= 100,000/mm^3 (within 14 days of registration)
• Hemoglobin > 9.0 g/dL (within 14 days of registration)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) (within 14 days of registration)
• Aspartate transaminase (aspartate aminotransferase [AST]) =< 2.5 x ULN (within 14 days of registration)
• Calculated creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (within 14 days of registration)
• Females of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])
• Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:

• Patient has received chemotherapy, targeted agent, or radiotherapy within 4 weeks or at least 5 half-lives, whichever is longer, prior to registration
• Palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:
• Repeat imaging demonstrates no new sites of bone metastases
• The lesion being considered for palliative radiation is not a target lesion
• Patient has received immunotherapy (including monoclonal antibodies) within 4 weeks prior to registration
• Patients who have not recovered to grade 1 or less from any adverse events due to agents administered more than 4 weeks earlier (excluding alopecia)
• Patients who are receiving any other investigational agents
• Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Patients who have received autologous stem cell transplant (ASCT) =< 12 weeks prior to the first dose of study drug
• Patients with a prior history of allogeneic stem cell or solid organ transplantation
• Patients with evidence of active disease in the central nervous system (CNS) defined as either the presence of active lesions on MRI obtained within 4 weeks of registration or progressive neurological decline
• Patients with primary CNS lymphoma who develop systemic recurrence following standard therapy may be included as long as no active CNS disease is present at the time or enrollment; similarly, patients with secondary involvement of the CNS from a systemic lymphoma may be included as long as the CNS disease has been optimally treated and they demonstrate no evidence of active CNS disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1127 (varlilumab) and/or nivolumab
• History of severe hypersensitivity reaction to any monoclonal antibody
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because CDX-1127 (varlilumab) and nivolumab are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CDX-1127 (varlilumab) or nivolumab, breastfeeding should be discontinued if the mother is treated with CDX-1127 (varlilumab) or nivolumab
• Patients with human immunodeficiency virus (HIV) are eligible for the study provided they meet the other protocol criteria in addition to the following:
• Undetectable HIV load by standard polymerase chain reaction (PCR) clinical assay within 60 days prior to registration
• Absolute CD4 count of >= 200 mm^3 within 60 days prior to registration
• Willing to maintain adherence to combination antiretroviral therapy
• No history of acquired immunodeficiency syndrome (AIDS) defining condition (other than lymphoma or CD4 cell count < 200 mm^3)
• Likely to have near normal lifespan if not for the presence of relapsed/refractory lymphoma
• Patients with evidence of hepatitis B virus (HBV) are eligible provided there is minimal hepatic injury and the patient has undetectable HBV on suppressive HBV therapy; patient must be willing to maintain adherence to HBV therapy
• Patients with previously treated and eradicated hepatitis C virus (HCV) who have minimal hepatic injury are eligible
• Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
• Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
• Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
• Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study
• Patients with other active malignancy =< 3 years prior to registration for which active treatment is required must be excluded; patients with composite lymphomas that have a non-B-cell component must be excluded EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
Biological: Nivolumab, Drug: Varlilumab
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Plasmablastic Lymphoma, ALK-Positive Large B-Cell Lymphoma, Atypical Burkitt/Burkitt-Like Lymphoma, Burkitt-Like Lymphoma With 11q Aberration, Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation, Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, EBV-Positive Mucocutaneous Ulcer, Human Herpesvirus 8-Positive Neoplastic Cells Present, Intravascular Large B-Cell Lymphoma, Large B-Cell Lymphoma With IRF4 Rearrangement, Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type, Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System, Primary Effusion Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Burkitt Lymphoma, Recurrent Lymphomatoid Granulomatosis, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Refractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Burkitt Lymphoma, Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Small Intestinal High Grade B-Cell Lymphoma, Not Otherwise Specified, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, High Grade B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
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Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Aravind Sanjeevaiah
171563
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03604991
STU-2019-0612
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Inclusion Criteria:

• STEP 1: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)
• STEP 1: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• STEP 1: Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy
• STEP 1: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
• STEP 1: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
• STEP 1: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
• STEP 1: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
• STEP 1: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
• STEP 1: Hemoglobin (Hgb) >= 9 g/dL (within less than or equal to 14 days prior to randomization)
• STEP 1: Leukocytes >= 3,000/mm^3 (within less than or equal to 14 days prior to randomization)
• STEP 1: Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy
• STEP 1: Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy
• STEP 1: Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy
• STEP 1: Patients must have no contraindication to receiving radiation therapy
• STEP 1: Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
• STEP 1: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
• STEP 1: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
• STEP 1: Adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs
• STEP 1: For patients with evidence of CHF, myocardial infarction (MI), cardiomyopathy, or myositis, cardiac evaluation including lab tests and cardiology consultations including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram
• STEP 1: Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility
• STEP 1: Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen
• STEP 1: Patients must not be receiving any other investigational agents
• STEP 1: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
• STEP 1: Women must not be pregnant or breast-feeding due to potential harm to the fetus from carboplatin, paclitaxel, or nivolumab. All females of childbearing potential must have a blood test or urine study done within 2 weeks prior to registration to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of starting nivolumab to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• STEP 1: Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy
• STEP 1: If patient says 'Yes' to "I choose to take part in the imaging study and will have the diffusion weighted magnetic resonance imaging (MRI) scans": patients must be able to tolerate MRI scans:
• No history of untreatable claustrophobia
• No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies
• Weight compatible with limits imposed by the MRI scanner table
• STEP 2: Patient registration must not exceed 12 weeks from time of esophagectomy
• STEP 2: Patients must have a post-operative ECOG performance status of 0-2
• STEP 2: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
• STEP 2: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
• STEP 2: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
• STEP 2: AST (SGOT)/ ALT (SGPT) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
• STEP 2: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
• STEP 2: Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical computed tomography (CT) scan
• STEP 2: Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
• STEP 2: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
• STEP 2: Patients must not be receiving any other investigational agents
• STEP 2: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
• STEP 2: Women must not be pregnant or breast-feeding due to potential harm to the fetus from nivolumab or ipilimumab. All females of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to registration to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy
• STEP 2: Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy
Drug: Carboplatin, Biological: Ipilimumab, Biological: Nivolumab, Drug: Paclitaxel, Radiation: Radiation Therapy
Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage II Esophageal Adenocarcinoma AJCC v8, Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage III Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
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Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease (ADMIRE-CD-II)

The purpose of this phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study
Call 214-648-5005
studyfinder@utsouthwestern.edu
Tasneem Ahmed
116579
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03279081
STU 052018-069
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Inclusion Criteria:
1. Signed informed consent 2. Patients of either gender ≥ 18 years and ≤75 years of age 3. Patients with Crohn's Disease (CD) diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria 4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings 5. Clinically controlled, non active or mildly active CD, during the last six months prior to Screening visit. 6. Patients whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or TNF-α antagonist or vedolizumab or ustekinumab, or having documented intolerance 7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both WCBP or male patients participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study.
Exclusion Criteria:
1. Concomitant rectovaginal or rectovesical fistula(s) 2. Patient naïve to prior specific medical treatment for complex perianal fistula(s) including IS or anti-TNFs. 3. Presence of a perianal collection > 2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon 4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large [> 0.5 cm diameter] ulcers in the rectum) that make impossible to follow the surgery procedure manual 5. Patient with diverting stomas 6. Active, uncontrolled infection requiring parenteral antibiotics 7. Patient with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit 8. Patients with major alteration on any of the following laboratory tests or increased risk for the surgical procedure: 1. Serum creatinine levels >1.5 times the ULN 2. Total bilirubin >1.5 ULN 3. AST/ALT >3 times ULN 4. Hemoglobin <10.0 g/dL 5. Platelets <75.0 x109/L 6. Albuminemia < 3.0 g/dL 9. Suspected or documented infectious enterocolitis within two weeks prior to Screening visit 10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Patients with basal-cell carcinoma of the skin completely resected outside the perineal region can be included 11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in patients increased risk from study participation and/or lack of compliance with study procedures 12. Patients with primary sclerosing cholangitis 13. Patients with known chronically active hepatopathy of any origin, including cirrhosis and patients with persistent positive HBV surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for HCV and quantitative HCV PCR within 6 months prior to Screening. 14. Congenital or acquired immunodeficiencies, including patients known to be HIV carriers 15. Known allergies or hypersensitivity to penicillin or aminoglycosides; DMEM (Dulbecco Modified Eagle's Medium); bovin serum; local anaesthetics or gadolinium (MRI contrast) 16. Contraindication to MRI scan (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia) 17. Severe trauma within 6 months prior to Screening visit 18. Pregnant or breastfeeding women 19. Patients who do not wish to or cannot comply with study procedures 20. Patients currently receiving, or having received any investigational drug within 3 months prior to Screening visit 21. Patients previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study 22. Any major surgery of the GI tract (including one or more segments of the colon or terminal ileum) within 6 months prior the screening or any minor surgery of the GI tract within 3 months prior to screening 23. Patients who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study 24. Contraindication to the anaesthetic procedure.
Drug: Cx601, Other: Placebo
Crohn's Disease
Crohn's disease, complex perianal fistula(s)
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Biological Effect of Warfarin on Pancreatic Cancer

This study aims to asses the effect of warfarin on markers of AXL pathway in patients with pancreatic adenocarcinoma.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT03536208
STU 022018-090
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Inclusion Criteria:

• Pathologically-confirmed, localized or metastatic adenocarcinoma of the pancreas. Diagnostic biopsy must be obtained at the study institution prior to enrollment. Pathology material must be available for review.
• Patient must have measurable disease per RECIST criteria
• Started most recent systemic therapy regimen within 15 days of enrollment (any line of therapy is allowed).
• Ability to tolerate, swallow and absorb oral medications.
• Ability to understand and the willingness to sign a written informed consent.
• Age > 18 years
• Negative blood pregnancy test within seven days of study entry for WOCBP
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:

• Active radiation therapy, or planned radiation therapy during study period
• Subjects may not be receiving any other investigational agents.
• Pregnant, nursing or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be potentially teratogenic.
• Underlying condition which may increase the risk of complications from warfarin therapy. These can include: Known major bleeding diathesis:
• Coagulopathy
• Significant GI bleed within 6 months,
• Clinically significant hematuria or hemoptysis,
• Thrombolytic therapy within one month of study entry,
• Active peptic ulcer disease with bleeding.
•Significant infection or other coexistent medical condition that would preclude protocol therapy including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Drug: Warfarin
Pancreatic Cancer
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A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW)

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, safety and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Aravind Sanjeevaiah
171563
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03653507
STU-2018-0213
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Inclusion Criteria:

• A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 6 months after the final study treatment administration
• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study treatment administration.
• Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study treatment administration.
• A male subject with female partner(s) of childbearing potential:
• must agree to use contraception during the treatment period and for 6 months after the final study treatment administration.
• A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration.
• Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
• Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
• Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
• Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
• Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
• Subject has ECOG performance status 0 or 1.
• Subject has predicted life expectancy ≥ 12 weeks.
• Subject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. In case of multiple central laboratory data within this period, the most recent data should be used to determine eligibility.
• Hemoglobin (Hb) ≥ 9 g/dl. NOTE: subject must not have received any growth factor or blood transfusions within 14 days prior to the hematology values obtained at screening. Subjects requiring transfusions to meet eligibility criteria are not eligible.
• Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L
• Platelets ≥ 100x10^9/L
• Albumin ≥ 2.5 g/dL
• Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
• Estimated creatinine clearance ≥ 30 mL/min
• Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)
Exclusion Criteria:

• Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment.
• Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was completed > 28 days prior to the first dose of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases ≥ 14 days prior to first dose of study treatment and has recovered from all acute toxicities is eligible.
• Subject has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to first dose of study treatment.
• Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) or a single dose of systemic corticosteroids is eligible.
• Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment.
• Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
• Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
• Subject has prior severe allergic reaction or intolerance to any component of CAPOX.
• Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Subject has gastric outlet syndrome or persistent/recurrent vomiting.
• Subject had recent gastric bleeding and/or is symptomatic with proven gastric ulcers that excludes the subject from participation.
• •Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or hepatitis C infection. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible.
• Subject has an active autoimmune disease that has required systemic treatment within the past 2 years.
• Subject has active infection requiring systemic therapy that has not completely resolved within 14 days prior to first dose of study treatment.
• Subject has significant cardiovascular disease, including any of the following:
• Congestive heart failure (defined as New York Heart Association [NYHA] Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident (CVA), or hypertensive crisis within 6 months prior to administration of first dose of study treatment;
• History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes);
• QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects;
• History or family history of congenital long QT syndrome
• Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to first dose of study treatment are eligible.)
• Subject has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Subject has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
• Subject has had a major surgical procedure ≤ 28 days prior to the first dose of study treatment.
• Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to the first dose of study treatment.
• Subject has psychiatric illness or social situations that would preclude study compliance.
• Subject has another malignancy for which treatment is required.
• Subject has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Drug: zolbetuximab, Drug: oxaliplatin, Drug: capecitabine, Drug: placebo
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
CLDN 18.2, gastroesophageal junction cancer, adenocarcinoma, IMAB362, oxaliplatin, HER2, claudiximab, capecitabine, gastric cancer, HER2 Negative, zolbetuximab
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Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (PRODUCE)

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit 50 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ashish Patel
60083
All
7 Years to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03301311
STU 032017-045
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Inclusion Criteria:

• Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
• Age 7-18 years
• Enrolled in the ImproveCareNow (ICN2) registry
• Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.
• Potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist.
Exclusion Criteria:
Complex and Unstable IBD:
• Currently or within the past 9 months has had an intra-abdominal abscess, fistula, stricturing CD, or ostomy
• Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of >60 assessed within three weeks of enrollment
• Ever had history of full colectomy
• Hospitalization or surgery planned within 3 months
• Ongoing active gastrointestinal infection
• Severe Malnutrition (BMI less than 5th percentile)
• Recent medication changes including:
• Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment
• Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment
• Vedolizumab started within 16 weeks prior to enrollment
• Increase in corticosteroids within 4 weeks of screening or have dose >20 mg prednisone or equivalent Evidence of Other Complicating Medical Issues:
• Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
• Serious psychological or psychiatric conditions such as eating disorders or self-harm
• Pregnancy
• Tobacco, alcohol, or illicit drug abuse Inability to Complete the Protocol
• Non-English speaking participants
• On SCD or modified SCD anytime within 8 weeks of enrollment
• If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study.
• Participants on a vegan diet
• Lack of smart phone and data plan for participating caregiver
• Participating in another concurrent intervention study
Other: Specific Carbohydrate Diet (SCD), Other: Modified Specific Carbohydrate Diet (MSCD)
Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases, Crohn Disease
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02465060
STU 082015-079
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Inclusion Criteria:

• ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)
• Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately
• Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:
• Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR
• Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 years
• Patients must have measurable disease
• Patients must meet the criteria below and have received results from one of the designated outside laboratories indicating a "rare variant" that is an actionable Mutation of Interest (aMOI) for specific select subprotocols.
• The following requirements apply:
• The outside laboratory specifically notified the site that patient may be a potential candidate for MATCH due to a detected "rare variant"; the outside lab reports are NOT sufficient for this purpose
• NOTE: The content and format of these specific notifications for the Outside Assay process will vary depending on the designated outside lab in question, as they are each responsible for their own outreach efforts; it is strongly recommended that the designated outside laboratory be contacted to confirm the format and receipt of this notification prior to registering any patients to Step 0
• Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following notification of treatment assignment
• NOTE: The receipt of this notification (and the start of the associated deadline for Step 1 registration) may occur shortly after Step 0 registration, since these patients will not be submitting tissue for screening purposes; however, for certain "rare variant" arms, submission of archival tissue for central immunohistochemistry (IHC) testing may be required
• Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met
• There is no particular window of time after notification of potential eligibility from an outside lab in which the patient must be registered to Step 0, but treatment slots will be assigned on a first come, first serve basis to those who do register to Step 0, and are not held for those notified of potential eligibility who do not register to Step 0
• Patients may have received other non-targeted, immunotherapy or targeted treatment between the prior genetic testing at the outside lab and registration to Step 0; the decision to stop such treatment in favor of participation in MATCH, if no further clinical benefit is expected, is per the treating physician's discretion; documentation of a lack of response to the prior treatment is not required in these cases
• NOTE: Other potential aMOIs that would be eligibility criteria for "NON RARE" arms, as determined by the designated laboratories, are not applicable for this process in MATCH
• NOTE: Tumor tissue for the confirmation of "rare variant" by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratory
• Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted
• NOTE: Warfarin may not be started while enrolled in the EAY131 study
• Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
• Patients must not currently be receiving any other investigational agents
• Patients must not have any uncontrolled intercurrent illness including, but not limited to:
• Symptomatic congestive heart failure (New York Heart Association [NYHA] classification of III/IV)
• Unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration to Step 0, 2, 4, 6
• Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2)
• Psychiatric illness/social situations that would limit compliance with study requirements
• Intra-cardiac defibrillators
• Known cardiac metastases
• Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
• NOTE: To receive an agent, patient must not have any uncontrolled intercurrent illness such as ongoing or active infection; patients with infections unlikely to be resolved within 2 weeks following screening should not be considered for the trial
• Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible
• Patients who are human immunodeficiency virus (HIV)-positive are eligible if:
• CD4+ cell count greater or equal to 250 cells/mm^3
• If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used
• No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
• Probable long-term survival with HIV if cancer were not present
• Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease
• NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist
• NOTE: For patients entering the study via the original screening process, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the only intervening treatment permitted is prior therapy that the patient already received prior to Step 0 registration; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment
• NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment
• Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below); patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)
• NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):
• Temporary steroid use: e.g. for computed tomography (CT) imaging in setting of contrast allergy
• Low dose steroid use for appetite
• Chronic inhaled steroid use
• Steroid injections for joint disease
• Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease
• Topical steroid
• Steroids required to manage toxicity related to study treatment, as described in the subprotocols
• Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy
• NOTE: Steroids must be completed alongside last dose of chemotherapy
• Leukocytes >= 3,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• Absolute neutrophil count >= 1,500/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• Platelets >= 100,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (up to 5 times ULN in presence of liver metastases) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:
• Resting corrected QT interval (QTc) =< 480 msec
• NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs
• The following only need to be assessed if the mean QTc > 480 msec
• Check potassium and magnesium serum levels
• Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc
• For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required
• For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc
• Patient must not have hypokalemia (value < institutional lower limit of normal)
• No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
• NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs
• ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1)
• If patients have been biopsied or submitted archived tumor tissue obtained within the last 6 months for assessment with the MATCH assays, patients may receive non-protocol treatment after biopsy/tissue submission (if clinically indicated) until they receive notification of results however, lack of response must be documented prior to registration to step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; for pat
Drug: Adavosertib, Drug: Afatinib, Drug: Afatinib Dimaleate, Drug: Binimetinib, Drug: Capivasertib, Drug: Copanlisib, Drug: Copanlisib Hydrochloride, Drug: Crizotinib, Other: Cytology Specimen Collection Procedure, Drug: Dabrafenib, Drug: Dabrafenib Mesylate, Drug: Dasatinib, Drug: Defactinib, Drug: Defactinib Hydrochloride, Drug: Erdafitinib, Drug: FGFR Inhibitor AZD4547, Drug: Ipatasertib, Other: Laboratory Biomarker Analysis, Drug: Larotrectinib, Drug: Larotrectinib Sulfate, Biological: Nivolumab, Drug: Osimertinib, Drug: Palbociclib, Biological: Pertuzumab, Drug: PI3K-beta Inhibitor GSK2636771, Drug: Sapanisertib, Drug: Sunitinib Malate, Drug: Taselisib, Drug: Trametinib, Biological: Trastuzumab, Biological: Trastuzumab Emtansine, Drug: Ulixertinib, Drug: Vismodegib
Recurrent Melanoma, Lymphoma, Melanoma, Recurrent Uterine Corpus Carcinoma, Glioma, Recurrent Ovarian Carcinoma, Recurrent Breast Carcinoma, Recurrent Pancreatic Carcinoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Recurrent Bladder Carcinoma, Recurrent Prostate Carcinoma, Breast Carcinoma, Recurrent Cervical Carcinoma, Thyroid Gland Carcinoma, Recurrent Colon Carcinoma, Recurrent Malignant Solid Neoplasm, Esophageal Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Cervical Carcinoma, Colon Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma, Kidney Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Lung Carcinoma, Malignant Uterine Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Plasma Cell Myeloma, Prostate Carcinoma, Rectal Carcinoma, Recurrent Colorectal Carcinoma, Recurrent Esophageal Carcinoma, Recurrent Gastric Carcinoma, Recurrent Glioma, Recurrent Head and Neck Carcinoma, Recurrent Liver Carcinoma, Recurrent Lung Carcinoma, Recurrent Lymphoma, Recurrent Rectal Carcinoma, Recurrent Skin Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Skin Carcinoma, Uterine Corpus Cancer
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Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer

The study will perform a clinical study evaluating the safety and tolerability of nintedanib when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and microvessel density.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02902484
STU 022016-083
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Inclusion Criteria:
1. Signed and dated written informed consent prior to admission to the study; 2. Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas; 3. At least one measurable disease lesion according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1); 4. Age ≥ 18 years; 5. No more than one prior line of non-gemcitabine/nab-paclitaxel containing systemic therapy for metastatic/locally advanced pancreatic cancer; 6. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1; 7. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration; (Note: contraception in patients with reproductive capacity will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.) 8. Adequate biological parameters at baseline (obtained within 14 days prior to registration). 9. If elevated liver function tests develop at the time of initial presentation or develop during workup and are the result of mechanical obstruction of the biliary drainage by tumor compression or invasion, a biliary drain may be placed. If drainage allows the liver function tests to come within inclusion criteria, the patient may be enrolled.
Exclusion Criteria:
1. More than one systemic therapy regimen of any type for metastatic or locally advanced disease. Adjuvant gemcitabine that ended more than 6 months from diagnosis of recurrent disease is not considered as a regimen; 2. Prior treatment with nintedanib or any other VEGFR inhibitor; 3. Known hypersensitivity to nintedanib, gemcitabine and nab-Paclitaxal peanut or soya or any other trial drug, their excipients or to contrast media; 4. Chemo-, hormon-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug; 5. Radiotherapy to the target lesion within the past 3 months prior to baseline imaging 6. Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy; 7. Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomization); 8. Leptomeningeal disease; 9. Radiographic evidence of cavitary or necrotic tumors; 10. Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial; 11. Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325mg per day); 12. Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period; 13. History of clinically significant hemorrhagic or thromboembolic event in the past 6 months; 14. Known inherited predisposition to bleeding or thrombosis; 15. Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion); 16. Proteinuria CTCAE grade 2 or greater; 17. Creatinine > 1.5 x ULN or GFR < 45 mL/min; 18. Hepatic function: total bilirubin outside of normal limits; ALT or AST > 1.5 ULN in pts without liver metastasis. For Pts with liver metastasis: total bilirubin outside of normal limits, ALT or AST > 2.5 ULN; 19. Coagulation parameters: International Normalized Ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN; 20. Absolute neutrophil count (ANC) < 1500/mL, platelets < 100,000/mL, Hemoglobin < 9.0 g/dl; 21. Any known active cancer other than pancreatic primary; 22. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy; 23. Active or chronic hepatitis C and/or B infection; 24. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug; 25. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study; 26. Pregnancy or breast feeding female; 27. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; 28. Active alcohol or drug abuse; 29. Significant weight loss (> 20% of BW) within past 6 months prior to inclusion into the trial or actual body weight of less than 50 kg; 30. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectable, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy.
Drug: Nintedanib
Cancer of Pancreas
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Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
Call 214-648-5005
studyfinder@utsouthwestern.edu
Marlyn Mayo
14698
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02955602
STU 112016-051
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Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations required by local law 2. 18 to 75 years old (inclusive) 3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
• History of AP above ULN for at least six months
• Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
• Documented liver biopsy result consistent with PBC 4. On a stable and recommended dose of UDCA for the past twelve months or intolerant to UDCA 5. AP ≥ 1.67 × ULN 6. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Exclusion Criteria:
1. A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment) 2. AST or ALT > 3 × ULN 3. Total bilirubin > 2.0 mg/dL 4. Total bilirubin > ULN AND albumin < LLN with the exception to subjects with Gilbert's Syndrome. Subjects with Gilbert's syndrome are excluded if Direct Bilirubin > ULN. 5. Auto-immune hepatitis 6. Primary sclerosing cholangitis 7. Known history of alpha-1-Antitrypsin deficiency 8. Known history of chronic viral hepatitis 9. Creatine kinase above ULN 10. Serum creatinine above ULN 11. For females, pregnancy or breast-feeding 12. Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening 13. Current use of fibrates or simvastatin 14. Current use of obeticholic acid 15. Use of an experimental or unapproved treatment for PBC 16. Use of experimental or unapproved immunosuppressant 17. Adverse event leading to MBX-8025 discontinuation from CymaBay's phase 2 PBC study (CB8025-21528) 18. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator
Drug: MBX-8025 2 mg Capsule, Drug: MBX-8025 5 mg Capsule, Drug: MBX-8025 10 mg Capsule
Primary Biliary Cirrhosis
PBC, Primary Biliary Cholangitis (PBC)
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Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis (ENTERPRET)

The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in subjects with moderately to severely active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined serum vedolizumab concentration threshold less than (<) 50 microgram per milliliter (microg/mL) and who are Week 6 non-responders based on partial Mayo score.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Tasneem Ahmed
116579
All
18 Years to 85 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT03029143
STU 042017-072
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Inclusion Criteria:
1. Has a diagnosis of UC established at least 1 month prior to Screening by clinical and endoscopic evidence and corroborated by a histopathology report. 2. Has moderately to severely active UC as determined by a complete Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 28 days prior to enrollment. 3. Has evidence of UC proximal to the rectum (≥15 cm of involved colon) prior to start of vedolizumab IV dosing. 4. Has been determined to be suitable for vedolizumab IV for routine management of UC by their physician. 5. Has a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening). 6. Has demonstrated an inadequate response with, lost response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or tumor necrosis factor-alpha (TNF-α) antagonists. Subject who are naive to TNF-α antagonist therapy or who have previously failed TNF-α antagonist therapy (including primary and secondary non-responders or intolerant) may be included. Week 6 Randomized Treatment Period Inclusion Criteria 7. Following Lead-in Period, the subject is assessed as having high vedolizumab drug clearance based on a predefined Week 5 serum vedolizumab concentration threshold (<50 microg/mL). 8. Following Lead-in Period, the subject is a non-responder based on partial Mayo score at Week 6.
Exclusion Criteria:
1. Has clinical evidence of abdominal abscess or toxic megacolon at the Screening Visit. 2. Has had an extensive colonic resection, subtotal or total colectomy. 3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 5. Has received any of the following for the treatment of underlying disease within 30 days of screening: 1. Non-biologic therapies (eg. cyclosporine, tacrolimus, thalidomide) 2. An approved non-biologic therapy in an investigational protocol. 6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives prior to screening (whichever is longer). 7. Has previously had prior exposure to approved or investigational anti-integrin antibodies (e.g. natalizumab, efalizumab, etrolizumab, AMG-181, anti-MAdCAM-1 antibodies or rituximab). 8. Has previously received approved or investigational vedolizumab. 9. The subject currently requires or is anticipated to require surgical intervention for UC during the study. 10. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia. 11. Has any evidence of an active infection during Screening (eg, sepsis, cytomegalovirus, or listeriosis). 12. Has a clinically significant infection (eg, pneumonia, pyelonephritis) within 30 days prior to screening, or ongoing chronic infection. 13. Has evidence of active C. difficile as evidenced by positive C. difficile toxin or is having treatment for C. difficile infection or other intestinal pathogens during Screening. 14. Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or chronic HBV (HBV immune subjects (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included), or hepatitis C virus (HCV) infection. Subjects with documented successful treatment of HCV with sustained virological response (SVR) at 26 weeks can be enrolled. 15. Has active or latent tuberculosis (TB), as evidenced by the following: a. A diagnostic TB test performed within 30 days of screening or during the Screening Period that is positive, defined as: i. Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR ii. A TB skin test reaction ≥ 5 mm OR, b. Chest X-ray within 3 months of screening that is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON tests within 30 days prior to Screening or during the Screening Period. 16. Has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, HIV infection, organ transplantation). 17. Has any live vaccination within 30 days prior to Screening or is planning to receive any live vaccination during participation in the study. 18. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks prior to Screening. 19. Has a history of hypersensitivity or allergies to vedolizumab IV or its components. 20. Has received total parenteral nutrition (TPN) or albumin in the last 30 days prior to screening. 21. Has any unstable or uncontrolled cardiovascular disorder, heart failure moderate to severe (New York Class Association III or IV), any pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety. 22. Has had a surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study period. 23. Has a history of malignancy, except for the following: adequately-treated non-metastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to Screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Subjects with remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case by-case basis prior to Screening. 24. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease. 25. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of the first dose of study drug on Day 1. 26. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.
Drug: Vedolizumab IV
Colitis, Ulcerative
Drug Therapy
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S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Syed Kazmi
177531
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03365882
STU 122017-016
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Inclusion Criteria:

• STEP 1 INITIAL REGISTRATION: HER2 TESTING
• Patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum that is metastatic or locally advanced and unresectable
• Mutation results:
• All patients must have molecular testing performed in a Clinical Laboratory Improvement Act (CLIA) certified lab which includes which includes KRAS and NRAS gene and exon 15 of BRAF gene (BRAF V600E mutation); patients with any known activating mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61] and exon 4 [codons 117 and 146]) of KRAS/NRAS genes and in exon 15 (BRAFV600E mutation) of BRAF gene are not eligible
• Patients must not have been treated with any of the following prior to step 1 initial registration:
• Cetuximab, panitumumab, or any other monoclonal antibody against EGFR or inhibitor of EGFR
• HER-2 targeting for treatment of colorectal cancer; patients who have received prior trastuzumab or pertuzumab for other indications such as prior history of adjuvant or neoadjuvant breast cancer treatment prior to the development of advanced colorectal cancer are eligible
• Patients must not have had history of severe toxicity and intolerance to or hypersensitivity to irinotecan or any other study drug; patients must not have had a severe infusion-related reaction during any prior therapy with pertuzumab or trastuzumab
• Patients must have tumor slides available for submission for HER-2 testing; HER-2 testing must be completed by the central lab prior to step 2 randomization
• Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines; for step 1 initial registration, the appropriate consent form is the step 1 consent form
• As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• STEP 2 RANDOMIZATION
• Patients must have HER-2 amplification as determined by central testing (3+ or 2+ by immunohistochemistry and HER-2 gene amplification by in situ hybridization with a ratio of HER-2 gene signals to centromere 17 signals >= 2.0)
• Patients must have measurable disease that is metastatic or locally advanced and unresectable; imaging used to assess all disease per RECIST 1.1 must have been completed within 28 days prior to step 2 randomization; all disease must be assessed and documented on the Baseline Tumor Assessment Form
• Patients must have had at least one prior regimen of systemic chemotherapy for metastatic or locally advanced, unresectable disease; patients must have progressed following the most recent therapy; prior treatment with irinotecan is allowed; for patients that received adjuvant chemotherapy: prior treatment for metastatic disease is not required for patient who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy; if the patient received one line of adjuvant treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of chemotherapy used to treat the metastatic or locally advanced, unresectable disease; patients who have received >= 3 lines of systemic chemotherapy for metastatic or locally advanced, unresectable disease are not eligible
• Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to step 2 randomization and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to step 2 randomization
• Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to step 2 randomization; eligible patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to step 2 randomization
• Patients must have a Zubrod performance status of 0 or 1
• Patients must have a complete physical examination and medical history within 28 days prior to step 2 randomization
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets >= 75,000/mcL
• Hemoglobin >= 9 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 5 x institutional upper limit of normal (IULN)
• Bilirubin =< 1.5 mg/dL
• Calculated creatinine clearance > 30 ml/min within 14 days prior to step 2 randomization
• Patients who have had an echocardiogram performed within 6 months prior to step 2 randomization must have ventricular ejection fraction (left ventricular ejection fraction [LVEF]) >= 50% or >= within normal limits for the institution
• Patients must not have an uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, severe infection, severe malnutrition, unstable angina, class III-IV New York Heart Association (NYHA) congestive heart failure, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within 6 months prior to step 2 randomization
• Patients must not have any known previous or concurrent condition suggesting susceptibility to hypersensitivity or allergic reactions, including, but not limited to: known hypersensitivity to any of the study treatments or to excipients of recombinant human or humanized antibodies; patients with mild or seasonal allergies may be included after discussion with the study chairs
• Patients must not be planning treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade lesions such as incidental appendix carcinoid, or any other cancer from which the patient has been disease and treatment free for two years; prostate cancer patients on active surveillance are eligible
• Patients must not be pregnant or nursing; females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method while on study and for at least 7 months after the last dose of study treatment; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Patients must be given the opportunity to consent to the optional submission of tissue for future research
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent form
• STEP 2 RANDOMIZATION: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have documented disease progression while on CETIRI (Arm 2) on this protocol; the Follow-up Tumor Assessment Form documenting disease progression must be submitted to Southwest Oncology Group (SWOG) prior to step 3 crossover registration; registration to step 3 crossover must be within 28 days of discontinuation of CETIRI protocol treatment; patients going off treatment for any other reason are not eligible
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have a Zubrod performance status of 0 or 1
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): ANC >= 1,500/mcL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Platelets >= 75,000/mcL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Hemoglobin >= 9 g/dL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): AST and ALT both =< 5 x institutional upper limit of normal (IULN)
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Bilirubin =< 1.5 mg/dL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Calculated creatinine clearance > 30 ml/min within 14 days prior to step 3 crossover registration
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have left ventricular ejection fraction (LVEF) >= 50% or >= lower limit of normal for the institution by echocardiogram within 14 days prior to step 3 crossover registration
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have a magnesium, potassium, calcium, sodium, bicarbonate, and chloride performed within 14 days prior to step 3 crossover registration
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent form
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Biological: Cetuximab, Drug: Irinotecan Hydrochloride, Other: Laboratory Biomarker Analysis, Biological: Pertuzumab, Biological: Trastuzumab, Device: HER-2 testing
Rectal Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage III Rectal Cancer AJCC v7, Colon Adenocarcinoma, ERBB2 Gene Amplification, Stage III Colon Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Colon Cancer AJCC v7, Stage IV Rectal Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7
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Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Jonathan Wickiser
60058
All
up to 30 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03533582
STU 062018-003
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Inclusion Criteria:

• Patients in Group F must have a body surface area (BSA) >= 0.6 m^2
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution
• Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining
• For all Group A patients, WDF status as determined by rapid review will be used to further stratify patients to Group A1 or A2
• For Groups B, C and D, rapid review is required if patients are either >= 8 years of age or have an alphafetoprotein (AFP) =< 100 at diagnosis
• For all Groups E and F patients, rapid central pathology review is required
• In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy
• Clinical situations in which emergent treatment may be indicated include, but are not limited to, the following circumstances:
• Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.)
• Uncorrectable coagulopathy
• For a patient to maintain eligibility for AHEP1531 when emergent treatment is given, the following must occur:
• The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alphafetoprotein (AFP), and must meet all AHEP1531 eligibility criteria at the time of emergent treatment
• Patient must be enrolled on AHEP1531 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP1531 enrollment
• Note: If the patient receives AHEP1531 chemotherapy emergently PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims
• Patients may have had surgical resection of the hepatic malignancy prior to enrollment; all other anti-cancer therapy for the current liver lesion is prohibited
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 or
• A serum creatinine based on age/gender as follows:
• Age: maximum serum creatinine (mg/dL)
• 1 month to < 6 months: 0.4 (male and female)
• 6 months to < 1 year: 0.5 (male and female)
• 1 to < 2 years: 06 (male and female)
• 2 to < 6 years: 0.8 (male and female)
• 6 to < 10 years: 1 (male and female)
• 10 to < 13 years: 1.2 (male and female)
• 13 to < 16 years: 1.5 (male), 1.4 (female)
• >= 16 years: 1.7 (male), 1.4 (female)
• Total bilirubin =< 5 x upper limit of normal (ULN) for age
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 10x upper limit of normal (ULN) for age
• Shortening fraction of >= 28% by echocardiogram (for patients on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior to study enrollment) or
• Ejection fraction of >= 47% by echocardiogram or radionuclide angiogram (for patients on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior to study enrollment)
• Group F patients only: QT/corrected QT (QTc) interval =< 450 milliseconds for males and =< 470 milliseconds for females (assessed within 8 weeks prior to study enrollment)
• Normal pulmonary function tests (including diffusion capacity of the lung for carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen) (for patients receiving chemotherapy [Groups A2, B, C, D, E2, F]); for patients who do not have respiratory symptoms or requirement for supplemental oxygen, pulmonary function tests (PFTs) are NOT required
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible
• Patients who are currently receiving another investigational drug
• Patients who are currently receiving other anticancer agents
• Patients with uncontrolled infection
• Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma
• Patients with hypersensitivity to any drugs on their expected treatment arm
• Group C: Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)
• Group D:
• Patients with chronic inflammatory bowel disease and/or bowel obstruction
• Patients with concomitant use of St. John?s wort, which cannot be stopped prior to the start of trial treatment
• Group F:
• Patients with peripheral sensitive neuropathy with functional impairment
• Patients with a personal or family history of congenital long QT syndrome
• This criteria apply ONLY to patients who will receive chemotherapy (all groups other than Groups A1 and E1):
• Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
• Lactating females who plan to breastfeed their infants
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
• Note for Group F: patients of childbearing potential should use effective birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment
Drug: Carboplatin, Drug: Cisplatin, Drug: Doxorubicin, Drug: Etoposide, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Other: Laboratory Biomarker Analysis, Drug: Oxaliplatin, Other: Patient Observation, Drug: Sorafenib, Drug: Vincristine Sulfate
Childhood Hepatocellular Carcinoma, Hepatoblastoma, Childhood Malignant Liver Neoplasm, Elevated Alpha-Fetoprotein, SMARCB1 Gene Mutation, Hepatocellular Malignant Neoplasm, Not Otherwise Specified
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Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Syed Kazmi
177531
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03233711
STU 062018-096
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Inclusion Criteria:

• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA
• Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the American Joint Committee on Cancer (AJCC) 8th edition; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology; individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal
• For patients registering to Arm T, patients must not have received prior chemoradiotherapy for anal cancer
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must have hemoglobin levels of > 10g/dL (within 2 weeks prior to registration)
• Patient must have a platelet count of > 100,000/mm^3 (within 2 weeks prior to registration)
• Patient's absolute neutrophil count (ANC) level must be > 1500/mm^3 (within 2 weeks prior to registration)
• Serum creatinine must be =< 1.5 X upper limit of normal (ULN) (within 2 weeks prior to registration)
• Total bilirubin must be < 2 X ULN (within 2 weeks prior to registration)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal (within 2 weeks prior to registration)
• Albumin >= 3.0 g/dL (within 2 weeks prior to registration)
• Patients known to be human immunodeficiency virus (HIV)+ are permitted; patients with CD4 > 200 and serum HIV viral load of < 200 copies/mm^3 are eligible, and in addition:
• Participants must be purified protein derivative (PPD) negative; alternatively, the QuantiFERON-tuberculosis (TB) Gold In-Tube (QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used; an individual is considered positive for M. tuberculosis infection if the IFN-gamma response to TB antigens is above the test cut-off (after subtracting the background IFN-gamma response in the negative control); the result must be obtained within 20 weeks prior to enrollment; PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment
• No history of acquired immune deficiency syndrome (AIDS)-related complications within past year other than a history of low CD4+ T-cell count (> 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to chemoradiotherapy and should not be used as an exclusion criterion if low
• Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer
• Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment
• Patient must have =< grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative;
• NOTE: HIV testing is not required for eligibility
• For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration
• Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded
• Women of child-bearing potential must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 5 months after the last dose of nivolumab; sexually active males must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 7 months after the last dose of nivolumab
• Women must not be pregnant or breast-feeding because the study drugs administered may cause harm to an unborn fetus or breastfeeding child; the effects of nivolumab on a developing fetus are unknown and may cause harm; all females of childbearing potential must have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration
• Pregnant women are excluded from this study because the study agents have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued
• Patients will be excluded if they have a T1 or M1, and T2N0 cancer
• Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus
• Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
• Any surgery must have been completed >= 4 weeks prior to starting study treatment
• No uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• Patient must not have active autoimmune disease that has required systemic treatment in the past 2 years
• NOTE: This does not include patients with controlled hypothyroidism
• No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
• No patients with immunodeficiency or receiving systemic steroid therapy equivalent to > 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication; topical corticosteroid or occasional inhaled corticosteroids are allowed
• No live vaccines within 30 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed; NOTE: no live vaccines may be administered while participating in the trial
• Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
• Previously irradiated patients (Arm S) must have received radiation per National Comprehensive Cancer Network guidelines; radiation therapy delivered on protocol (Arm T) will be reviewed
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients will be registered within 63 days following completion of standard chemoradiation for anal cancer; standard chemoradiation therapy is as defined
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th edition; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology; individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have received at least 54 gray (Gy) of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region) for the treatment of the anal cancer
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have ECOG performance status of 0-2
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have hemoglobin levels of > 10g/dL (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must have a platelet count of > 100,000/mm^3 (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient's ANC level must be > 1500/mm^3 (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Serum creatinine must be =< 1.5 X ULN (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Total bilirubin must be < 2 X ULN (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: AST (SGOT)/ALT (SGPT) =< 2.5 X institutional upper limit of normal (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Albumin >= 3.0 g/dL (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients known to be human immunodeficiency virus (HIV)+ patients with CD4 > 200 and serum HIV viral load of < 200 copies/mm^3 are eligible; in addition:
• Participants must be PPD negative; alternatively, the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used; an individual is considered positive for M. tuberculosis infection if the IFN-gamma response to TB antigens is above the test cut-off (after subtracting the background IFN-gamma response in the negative control); the result must be obtained within 20 weeks prior to enrollment; PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment; NOTE: If patient completed chemoradiation on Step 1, PPD testing does not need to be performed again
• No history of AIDS-related complications within past year other than a history of low CD4+ T-cell count (> 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to chemoradiotherapy should not be used as an exclusion criterion if low
• Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer
• Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment
• Patient must have =< grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative)
• NOTE: HIV testing is not required for eligibility
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Scans done within 4 weeks of randomization to Step 2
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must have recovered from all toxicities associated with chemoradiotherapy for anal cancer, to grade =< 1 with the exception of alopecia
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Women of child-bearing potential must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 5 months after the last dose of nivolumab; sexually active males must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 7 months after the last dose of nivolumab
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Women must not be pregnant or breast-feeding because the study drugs administered may cause harm to an unborn fetus or breastfeeding child; the effects of nivolumab on a developing fetus are unknown and may cause harm; all females of childbearing potential must have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Pregnant women are excluded from this study because the study agents have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must not have active autoimmune disease that has required systemic treatment in past 2 years
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No patients with immunodeficiency or receiving systemic steroid therapy equivalent to > 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication; topical corticosteroid or occasional inhaled corticosteroids are allowed
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No live vaccines within 3
Biological: Nivolumab, Other: Patient Observation
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Anal Margin Squamous Cell Carcinoma, Stage IIB Anal Cancer AJCC v8, Stage IIIA Anal Cancer AJCC v8, Stage IIIB Anal Cancer AJCC v8, Stage IIIC Anal Cancer AJCC v8
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Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT02834780
STU 112017-020
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Inclusion criteria: 1. Participants with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). 2. Must have had at least one prior standard-of-care therapy, unless contraindicated. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1 (Part 2 only). 5. Adequate bone marrow and organ function. Exclusion criteria: 1. Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C (HCV). 2. Known human immunodeficiency virus (HIV) infection. 3. Presence of gastric or esophageal varices requiring active treatment. 4. Previous treatment with selective FGF19-FGFR4 targeted therapy. 5. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures.
Drug: H3B-6527
Liver Cancer, Hepatocellular Carcinoma, Liver Neoplasms, Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Advanced Hepatocellular Carcinoma, Hepatic Cancer, Hepatic Carcinoma, Bile Duct Cancer
Advanced Hepatocellular Carcinoma, H3B-6527, Intrahepatic Cholangiocarcinoma, FGFR4, FGF19
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Safety, Tolerability and Pharmacodynamics of SYNB1020

This is a phase 1b/2a, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients.
Call 214-648-5005
studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years to 75 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03447730
STU 072018-057
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Key
Inclusion Criteria:

• Age 18 to 74 years
• Females must be of non childbearing potential
• Able and willing to complete informed consent process
• Available for and agree to all study procedures
• Screening laboratory evaluations within defined acceptable limits or judged to be not clinically significant by the Investigator
• Diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
• Evidence of elevated portal hypertension by either liver stiffness measurement, the presence of abdominal or esophageal varices, splenomegaly or ascites (Part 2 only)
• Elevated venous ammonia (Part 2 only) Key
Exclusion Criteria:

• Body mass index < 18.5 or ≥ 40 kg/m2
• Administration or ingestion of an investigational drug within 8 weeks or 5 half-lives, whichever is longer, prior to screening or current enrollment in an investigational study
• Allergy to ranitidine or intolerance to any of the excipients (glycerol, CS Health Easy Fiber.
• Any condition, prescription medication or over-the-counter product that may possibly affect absorption of medications or nutrients
• Dependence on drugs of abuse
• Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, or laboratory abnormality that may increase the patient risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the safety, kinetics, or pharmacodynamics results, and, in the judgment of the investigator, make the patient inappropriate for enrollment
• Current of past HE of Grade 2 or higher requiring hospitalization
• Child-Turcotte-Pugh score > 9
• History of liver transplant
Drug: SYNB1020, Other: Placebo
Cirrhosis
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OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis (OPTION)

The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Meghana Sathe
68730
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03746483
STU-2018-0396
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Inclusion Criteria:
1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus initial diagnostic sweat chloride ≥ 60 mmol/L 2. Under stable dose of porcine PERT 3. A fair or better nutritional status 4. Fecal elastase <100 µg/g 5. Standard-of-care medications including CFTR modulators are allowed
Exclusion Criteria:
1. History or diagnosis of fibrosing colonopathy 2. Any chronic diarrheal illness unrelated to pancreatic insufficiency 3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit 4. Feeding via an enteral tube during 6 months before screening 5. Forced expiratory volume ≤30% at the Screening visit
Drug: MS1819-SD, Drug: Porcine PERT
Cystic Fibrosis (CF), Exocrine Pancreatic Insufficiency (EPI)
Exocrine pancreatic insufficiency, EPI, Cystic Fibrosis, CF, Pancreatic enzyme replacement therapy, Lipase
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design (ASPIRe)

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.
Call 214-648-5005
studyfinder@utsouthwestern.edu
David Rahn
49553
Female
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02676973
STU 042016-010
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Inclusion Criteria:
1. Women age 21 or older 2. Prior total hysterectomy (no cervix present) 3. Prolapse beyond the hymen (defined as Ba, C, or Bp > 0 cm) 4. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C> -2/3 TVL) 5. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out' 6. Desires surgical treatment for post-hysterectomy vaginal prolapse 7. Available for up to 60 month follow-up
Exclusion Criteria:
1. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments 2. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse * 3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess 4. Unresolved chronic pelvic pain-active 5. Prior abdominal or pelvic radiation 6. Contraindication to any of the index surgical procedures
• Known Horseshoe Kidney or Pelvic Mass overlying the sacrum
• Active diverticular abscess or active diverticulitis
• Shortened vaginal length (<6 cm TVL)
• NOTE:
• Only documented SSLS will be an exclusion.
• Mesh used for only mid-urethral sling will NOT be an exclusion
• If prior POP repair is unknown and unable to be documented, subjects will be eligible based on clinician judgment. The investigator will examine and assess for evidence of mesh or graft if no evidence of mesh or graft is present on examination subject remains eligible.
Procedure: Open, Robotic, or Laparoscopic, Procedure: Transvaginal Native Tissue Repair, Procedure: Uphold™ LITE
Visceral Prolapse
pelvic organ prolapse, POP, vault prolapse, cystocele, vaginal prolapse, post-hysterectomy vaginal prolapse
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Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Todd Aguilera
176733
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT01926197
STU 102015-019
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Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the pancreas.
• Induction mFolfirinox up to 4 cycles. Informed consent must be signed by the end of the second cycle.
• Stable or better disease on re-staging scans.
• Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
• Typically, pancreatic tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibility will be based upon satisfying the radiation normal tissue constraints as per protocol.
• ECOG 0, 1, or 2
• Patients must have acceptable organ and marrow function as defined below and within 30 days of eligibility confirmation:
• leukocytes (WBC) >=3,000/mL
• absolute neutrophil count (ANC)>=1,500mL
• platelets >=50,000/mL
• total bilirubin < or = 1.5 X institutional upper limit of normal
• AST(SGOT)/ALT(SGPT) < or =2.5 X institutional upper limit of normal
• creatinine within normal institutional limits
• Ability to understand and the willingness to sign an informed consent form.
• Life expectancy > 6 months.
Exclusion Criteria:

• Metastatic disease
• Patients who have had prior radiotherapy to the upper abdomen/liver.
• Patients who have received chemotherapy for pancreatic cancer, other than up to 4 cycles of mFolfirinox.
• Children are excluded because pancreatic tumors rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
• Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Drug: Oxaliplatin, Radiation: SBRT, Drug: Irinotecan, Drug: Leucovorin, Drug: 5FU
Pancreatic Cancer
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NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing (Cardinal PRO)

This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy. Primary outcomes will include rates of wound healing, time to closure by secondary intention, and recurrence rate.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Lawrence Lavery
116716
All
18 Years to 89 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02519621
STU 032015-099
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Inclusion Criteria:

• Presents with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
• Wound presents with full thickness loss of epidermis and dermis
• The presentation of a wound that in the opinion of the investigators will require surgical debridement, and the wound is expected to be a good candidate for NPWT and eventual wound closure.
• ABI≥0.5 or toe pressures >30 PVR/mmHg
• Subject is willing and able to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described herein.
• 18 years of age or older
Exclusion Criteria:

• Does not present with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft, or a definitive diagnosis cannot be made, as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
• Wound does not present with full thickness loss of epidermis and dermis
• ABI<0.5 or toe pressures <30 PVR/mmHg
• Subject is not willing or is not able or it is not medically prudent for the subject to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described.
• Subject is unwilling or unable to use the NPWT device at home
• Active Charcot arthropathy
• Collagen vascular disease
• Scleroderma
• Non-enteric and unexplored fistula
• Necrotic tissue with eschar present after debridement
• General skin disorder in the area of the wound such as psoriasis or penicilitis
• Malnutrition (defined as BMI <19)
• Hypercoagulable state based on documentation in their medical record
• Acute deep vein thrombosis
• Current active malignancy in the wound
• Current melanoma or history of melanoma at the wound
• Current active or history of invasive squamous cell carcinoma at the wound
• Sepsis (defined as positive blood culture with leukocytosis) and temperature >101.5 at the time of screening
• Significant Hematologic disorders EXCLUDING anemia
• HIV
• Fever at screening > 101.5
• Deep X-ray therapy
• Untreated bone or soft tissue infection (osteomyelitis)
• Any concomitant illness(es) or medical condition(s) that in the opinion of the investigator would render the subject not suited for study participation
• Subject is taking a regimen of any medication(s) in a significant enough dosage that may affect chronic wound healing, including corticosteroid, chemotherapeutic and non-steroidal anti-inflammatory (NSAID) medications
• Less than 18 years of age
• Developmental disability/significant psychological disorder that could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
• Females currently pregnant or planning pregnancy during the course of intended participation in the study
• Active alcohol or substance abuse in the opinion of the investigator that could impair the subjects ability to provide informed consent, participate in the study protocol or record study measures.
Device: NPWT PRO without irrigation, Device: NPWT PRO with irrigation, Device: KCI Ulta
Partial-thickness Burn, Ulcer
diabetic ulcer, pressure ulcer, chronic or traumatic wound, sub-acute or dehisced wound
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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual 04/15/2019) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual 04/15/2019) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual 3/15/2019) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017) 24. Pheochromocytoma, malignant 25. Paraganglioma (closed to accrual 11/29/2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11/29/2018) 31. Adrenal cortical tumors (closed to accrual 06/27/2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02834013
STU 052017-020
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Inclusion Criteria:

• Patients are eligible under ONE of the following criteria:
• For all cohorts except the gestational trophoblastic disease (GTD) (Cohort #47), patients must have histologically and/or biochemically confirmed rare cancer and must be able to submit specimens. To be eligible for the GTD cohort: patients must have disease confirmed by quantitative serum beta-human chorionic gonadotropin (hCG) within 28 days prior to registration and must be able to submit blood specimens (tissue submission is not required for patients who will be registered to the GTD cohort [Cohort #47]); NOTE: Subsequent to site's Institutional Review Board (IRB) approval of revision 3, patients are NOT required to participate in EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" to register to S1609 OR
• FOR PATIENTS WITH PD-L1 AMPLIFICATION ONLY: All solid tumors (excluding lymphoma) are allowed for the PD-L1 amplified cohort if they have PD-L1 amplification; PD-L1 amplification is defined as having deoxyribonucleic acid (DNA) copy number of equal to or greater than six by any of the following Clinical Laboratory Improvement Act (CLIA)-approved next generation sequencing (NGS) tests: Foundation Medicine, Caris, MSK Impact, MD Anderson, Tempus, or Neogenomics; (fluorescence in situ hybridization [FISH] is not allowed); the assay must be done at or after the diagnosis of advanced disease, but PRIOR TO REGISTRATION OR
• FOR PATIENTS ENROLLED IN EAY131 "NCI-MATCH" PRIOR TO EAY131 ADDENDUM 10 ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off protocol treatment on EAY131, "NCI-MATCH" and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH" or who are otherwise unable to receive EAY131, "NCI-MATCH" therapy
• Patients who do not qualify for one of the histologic cohorts and are not on the ineligible histology list may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email
• NOTE: The "Not Otherwise Categorized" Rare Tumors cohort was permanently closed to accrual on 3/15/2019
• Patients who are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
• NOTE: The "Tumor of unknown primary (Cancer of Unknown Primary; CuP" cohort was permanently closed to accrual on 12/22/2017
• Patients must also meet one of the following:
• Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR
• Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• For all cohorts except the GTD cohort (Cohort #47): Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; scans must include imaging of the chest, abdomen and pelvis, with the exception of patients with head/neck cancer, who must have imaging of the chest, abdomen, pelvis and neck; if there is clinical suspicion for bone metastases at the time of enrollment (in the judgement of the treating investigator) bone scan should be performed; bone scans done within 42 days prior to registration may be used to establish baseline condition at registration
• No other prior malignancy is allowed except for the following:
• Adequately managed stage I or II cancer from which the patient is currently in complete remission
• Any other cancer from which the patient has been disease free for one year
• Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
• Note: Second primary tumors are not allowed concurrent with any of the eligible rare cancers
• For all cohorts except the PD-L1 amplified tumors cohort (Cohort # 50): Patients may have received either prior anti-CTLA4 or other prior anti-PD-1/anti-PD-L1 therapy, but not both, provided that it is completed >= 4 weeks prior to registration. To be eligible for the PD-L1 amplified tumors cohort (Cohort #50): Patients must not have received anti-PD-1/anti-PD-L1 therapy; prior anti-CTLA-4 is allowed provided that it is completed >= 4 weeks prior to registration
• Patients who had prior grade 3 or higher immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
• Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible
• Patients are not eligible if they have had or are planned for solid organ transplant
• Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; these patients must also have a CT or MRI of the brain to evaluate for CNS disease within 42 days prior to registration to S1609; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration
• Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before registration to S1609
• Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab
• Hormonal or endocrine blockade is permitted as long as patient has demonstrated progression on prior therapy (e.g. gonadotrophin releasing hormone [GnRH], somatostatin); long-acting somatostatin analogs (including octreotide) and androgen deprivation treatment (including long-acting leuprolide) are permitted while on protocol therapy
• Patients must have a Zubrod performance status of 0-2
• Absolute neutrophil count (ANC) >= 1,000/mcL (within 28 days prior to registration)
• Platelets >= 75,000/mcL (within 28 days prior to registration)
• Hemoglobin >= 8 g/dL (within 28 days prior to registration)
• Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin =< 3.0 x IULN (within 28 days prior to registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN (within 28 days prior to registration)
• Serum creatinine =< 2.0 x IULN (within 28 days prior to registration)
• Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight (within 28 days prior to registration)
• Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable if per institutional standard; patients who have undergone thyroidectomy or who are on thyroid suppression for their cancer are not required to have normal TSH and free T4
• Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the institutional normal ranges OR cortisol levels within institutional normal ranges (ante meridiem [AM] cortisol preferred), within 28 days prior to registration; Note: ACTH and cortisol levels are not required for patients with primary adrenal tumors (e.g. adrenocortical carcinoma)
• For women of childbearing potential, the local investigator must rule out pregnancy; Except for Cohorts 13 and 47, where tumor types may express beta-hCG, women of childbearing potential must have a serum or urine pregnancy test within 7 days prior to registration; for Cohorts 13 and 47, where tumor types may produce hCG (e.g. germ cell tumors or trophoblastic disease), other pregnancy exclusion methods should be used to rule out pregnancy, such as ultrasound examination, documented history of effective contraception, or documented infertility; all females of childbearing potential must have been demonstrated not to be pregnant within 7 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing due to risk of fetal or nursing infant harm; women of childbearing potential must have agreed to use an effective contraceptive method; a woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures
• Men of reproductive potential must have agreed to use birth control throughout the study and for 31 weeks after completion of protocol therapy; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he is responsible for beginning contraceptive measures
• Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible
• Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration:
• CD4+ cell count greater or equal to 250 cells/mm^3
• No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
• Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Chron's disease), as well as symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years is permitted; short-term steroid premedication for contrast allergy is permitted
• Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)
• Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
• Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration
• Patients must not have symptomatic interstitial lung disease or pneumonitis
• Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration
Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Chordoma, Mucinous Adenocarcinoma, Cervical Adenocarcinoma, Gestational Trophoblastic Tumor, Cholangiocarcinoma, Pancreatic Acinar Cell Carcinoma, Ovarian Clear Cell Adenocarcinoma, Lung Carcinoid Tumor, Acinar Cell Carcinoma, Adrenal Cortex Carcinoma, Adrenal Gland Pheochromocytoma, Anal Canal Neuroendocrine Carcinoma, Anal Canal Undifferentiated Carcinoma, Appendix Mucinous Adenocarcinoma, Bladder Adenocarcinoma, Colorectal Squamous Cell Carcinoma, Endometrioid Adenocarcinoma, Esophageal Neuroendocrine Carcinoma, Esophageal Undifferentiated Carcinoma, Extrahepatic Bile Duct Carcinoma, Fallopian Tube Adenocarcinoma, Fibromyxoid Tumor, Gastric Neuroendocrine Carcinoma, Gastric Squamous Cell Carcinoma, Giant Cell Carcinoma, Intestinal Neuroendocrine Carcinoma, Intrahepatic Cholangiocarcinoma, Lung Sarcomatoid Carcinoma, Major Salivary Gland Carcinoma, Malignant Odontogenic Neoplasm, Malignant Peripheral Nerve Sheath Tumor, Malignant Testicular Sex Cord-Stromal Tumor, Mixed Mesodermal (Mullerian) Tumor, Mucinous Cystadenocarcinoma, Nasal Cavity Adenocarcinoma, Nasal Cavity Carcinoma, Nasopharyngeal Carcinoma, Nasopharyngeal Papillary Adenocarcinoma, Nasopharyngeal Undifferentiated Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Undifferentiated Carcinoma, Ovarian Adenocarcinoma, Ovarian Germ Cell Tumor, Ovarian Mucinous Adenocarcinoma, Ovarian Squamous Cell Carcinoma, Pancreatic Neuroendocrine Carcinoma, Paraganglioma, Paranasal Sinus Adenocarcinoma, Paranasal Sinus Carcinoma, Parathyroid Gland Carcinoma, Pituitary Gland Carcinoma, Placental Choriocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Pseudomyxoma Peritonei, Scrotal Squamous Cell Carcinoma, Seminal Vesicle Adenocarcinoma, Seminoma, Serous Cystadenocarcinoma, Small Intestinal Adenocarcinoma, Small Intestinal Squamous Cell Carcinoma, Spindle Cell Neoplasm, Squamous Cell Carcinoma of the Penis, Testicular Non-Seminomatous Germ Cell Tumor, Thyroid Gland Carcinoma, Tracheal Carcinoma, Transitional Cell Carcinoma, Ureter Adenocarcinoma, Ureter Squamous Cell Carcinoma, Urethral Adenocarcinoma, Urethral Squamous Cell Carcinoma, Vaginal Adenocarcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified, PEComa, Fallopian Tube Transitional Cell Carcinoma, Ovarian Transitional Cell Carcinoma, Bartholin Gland Transitional Cell Carcinoma, Endometrial Transitional Cell Carcinoma, Minimally Invasive Lung Adenocarcinoma, Desmoid-Type Fibromatosis, Adenoid Cystic Carcinoma, Gastrointestinal Stromal Tumor, Metaplastic Breast Carcinoma, Rare Disorder, Vulvar Carcinoma, Gastric Undifferentiated Carcinoma, Solid Neoplasm, Angiosarcoma, Apocrine Neoplasm, Basal Cell Carcinoma, Cervical Clear Cell Adenocarcinoma, Extramammary Paget Disease, Gallbladder Carcinoma, Metastatic Malignant Neoplasm of Unknown Primary, Peritoneal Mesothelioma, Teratoma With Somatic-type Malignancy
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