UTSW - Study Finder

Optical Coherence Tomography Angiography in Neurological Disease

Description:

Optical Coherence Tomography Angiography (OCTA) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. Previous literature has demonstrated the potential of OCTA as a screening tool in stroke, but its utility in other neurological illness such as intracranial hemorrhage is unclear. Hence, this pilot study will gather preliminary data to support future grant applications to investigate this area more fully by recruiting patients with neurological illness and healthy controls and comparing their OCTA imaging parameters.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Emily.Melikman@UTSouthwestern.edu

Principal Investigator: Noah Jouett

Gender: ALL

Age: 18 Years to old

Phase:

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06797765

IRB Number: STU-2024-0876

Show full eligibility criteria

Interventions: DEVICE: OCTA

Conditions: Octa, Stroke, Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Brain and Nervous System

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Effect of the Stellate Ganglion Block on the Retinal Microcirculation

Description:

Surges in the sympathetic nervous system occur at the ictus of a variety of neurological critical illnesses including intracranial hemorrhage and ischemic stroke. It is hypothesized that these exaggerated increases in sympathetic nervous activity produce maladaptations that promote secondary brain injury. One of these possible mechanisms include diffuse vasospasm that cause cerebral ischemia. Hence, methods to abrogate the sympathetic nervous system in this context are under active investigation. One possible method is the regional anesthesia technique of the stellate ganglion nerve block, which is ordinarily used for complex regional pain syndrome, but has been shown to reduce cerebral sympathetic activity and reduces vasospasm in patients with subarachnoid hemorrhage. However, its effect on the microcirculation is not clear. Hence, we propose to study patients receiving the stellate ganglion nerve block as part of their standard medical care and to image their retinal microcirculation before and after the procedure using Optical Coherence Tomography Angiography (OCTA).

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Emily.Melikman@UTSouthwestern.edu

Principal Investigator: Noah Jouett

Gender: ALL

Age: 18 Years to old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06797752

IRB Number: STU-2024-1027

Show full eligibility criteria

Interventions: DEVICE: OCTA Scan

Conditions: Octa, Severe Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy (OrigAMI-3)

Description:

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Syed Kazmi

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06750094

IRB Number: STU20250287

Show full eligibility criteria

Inclusion Criteria:

* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease * Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing * Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible * Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 * Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

Exclusion Criteria:

* Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI * Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments * Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor * Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

Interventions: BIOLOGICAL: Amivantamab, BIOLOGICAL: Cetuximab, BIOLOGICAL: Bevacizumab, DRUG: 5-fluorouracil, DRUG: Leucovorin calcium/Levoleucovorin, DRUG: Irinotecan

Conditions: Colorectal Neoplasms, Colon, Rectum

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

Description:

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, JOSE.SANTOYO@UTSouthwestern.edu

Principal Investigator: Darin Okuda

Gender: ALL

Age: 18 Years to 55 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06735248

IRB Number: STU-2024-0883

Show full eligibility criteria

Inclusion Criteria:

* Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and review of any previously conducted cardiac monitoring. * Participants who are Epstein-Barr virus (EBV)-seropositive at screening. * Participants diagnosed with relapsing multiple sclerosis, including those with a single clinical attack (that is, clinically isolated syndrome \[CIS\]), as well as participants diagnosed with radiologically isolated syndrome, within 24 months of Screening Visit (that is, early in their multiple sclerosis course) and in the opinion of the Investigator have been neurologically stable for at least 30 days prior to Visit 1/Day 1. * A participant who could become pregnant is eligible to participate if they are not pregnant or breast/chest feeding and using a highly effective contraceptive method.

Exclusion Criteria:

* Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4 Fahrenheit °F\]) within 72 hours prior to or at screening or Day 1. * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 \[COVID-19\] regardless of vaccine type) within 28 days before or after any study injection, or within 14 days before or after any study injection for the influenza vaccine. * Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) * Participants with any documented history of myocarditis, pericarditis, or myopericarditis. * Has donated ≥450 milliliter (mL) of blood products within 28 days prior to screening or plans to donate blood products within 28 days post-study injection. Note: Other inclusion and exclusion criteria may apply.

Interventions: BIOLOGICAL: mRNA-1195, BIOLOGICAL: Placebo

Conditions: Multiple Sclerosis, Brain and Nervous System

Keywords: Multiple Sclerosis, mRNA-1195, MS

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (SUPRAME)

Description:

This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Sanjay Chandrasekaran

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06743126

IRB Number: STU20251515

Show full eligibility criteria

Inclusion Criteria:

* Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma * Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient * Life expectancy more than 6 months * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.

Exclusion Criteria:

* Primary mucosal or uveal melanoma and melanoma of unknown primary * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years * Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents. * History of cardiac conditions as per protocol * Prior allogenic stem cell transplantation or solid organ transplantation * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician * History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs * Known hypersensitivity to any of the rescue medications * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. * Any condition contraindicating leukapheresis * Pregnant or breastfeeding * Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment) * Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis, * Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis. * Patients with any active infection or ongoing reactivation of infection * Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months * Prior treatment with IMA203 * Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months * Patients with LDH greater than 2.0-fold ULN * Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment * Patients with active brain metastases or leptomeningeal metastases * Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization * Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment * Other protocol defined inclusion/exclusion criteria could apply

Interventions: BIOLOGICAL: IMA203, BIOLOGICAL: nivolumab plus relatlimab, BIOLOGICAL: lifileucel, BIOLOGICAL: nivolumab, BIOLOGICAL: pembrolizumab, BIOLOGICAL: ipilimumab, DRUG: Dacarbazine, DRUG: temozolomide, DRUG: paclitaxel, DRUG: paclitaxel plus carboplatin, DRUG: Albumin-Bound Paclitaxel

Conditions: Melanoma, Cutaneous Malignant, Melanoma, skin

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 (P300)

Description:

This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with Abiraterone acetate, Olaparib or 177Lu-PSMA-617 in patients with metastatic castration-resistant prostrate cancer (mCRPC).

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Tian Zhang

Gender: MALE

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06785636

IRB Number: STU20250584

Show full eligibility criteria

Interventions: DRUG: Pocenbrodib, DRUG: Cohort 2A (Pocenbrodib monotherapy), Cohort 2B (Pocenbrodib + abiraterone acetate), Cohort 2C (Pocenbrodib + olaparib), Cohort 2D (Pocenbrodib + 177Lu-PSMA-617

Conditions: mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Neoplasms, Male, Urogenital Neoplasms, Urogenital Cancers, Prostatic Diseases, Prostatic Neoplasms, Male Urogenital Diseases, Neoplasms, Neoplasms by Site, Prostate Cancer, Prostate

Keywords: mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,, Procenbrodib, castration resistant

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

Description:

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Terrell.Martinez@UTSouthwestern.edu

Principal Investigator: Natalie Tapaskar

Gender: ALL

Age: 18 Years to 85 Years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06736574

IRB Number: STU20251517

Show full eligibility criteria

Inclusion Criteria:

Adult patients who meet all the following criteria at screening may be included in the study: * Are between ≥ 18 years and ≤ 85 years at the signing of informed consent * Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening * Are receiving oral loop diuretics * Patients without AFF on screening ECG: * LVEF \< 30% within 6 months of screening * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL) * Patients with AFF on screening ECG: * LVEF \< 25% within 6 months of screening * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL) * Not currently taking digoxin * Are currently hospitalized with the primary reason of HF, or had an HF event within 6 months prior to screening * Are established on regional standard-of-care HF therapies for at least 30 days prior to screening * Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 mmHg

Exclusion Criteria:

Any of the following criteria will exclude potential patients from the study: * Have AFF on the screening ECG and are currently taking digoxin * Have had acute coronary syndrome, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization therapy within 3 months of screening * Are admitted to a long-term care facility or hospice * Have a projected survival of \< 12 months due to non-cardiovascular causes based on clinical judgment * Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening * Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening * Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening * Have an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 or receiving dialysis at screening * Have previously had a solid organ transplant * Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening * Have previously received omecamtiv mecarbil * Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP

Interventions: DRUG: Omecamtiv Mecarbil (OM), DRUG: Placebo

Conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction

Keywords: CK-1827452, omecamtiv mecarbil

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung

Description:

The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Kenneth Westover

Gender: ALL

Age: 18 Years to old

Phase: EARLY_PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06712745

IRB Number: STU-2024-1215

Show full eligibility criteria

Inclusion Criteria:

• Age ≥ 18 years of age.
• Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site.
• Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.
• Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.
• Zubrod/ECOG Performance Status 0-2 within 30 days prior to registration.
• Ability to tolerate MRI.
• All men, as well as women of child-bearing potential\* must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of consent, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Note: A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, 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:

• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression.
• Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
• Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.

Interventions: RADIATION: Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)

Conditions: Cancer, Lung, Metastasis, Lung/Thoracic

Keywords: lung, central lumg, cancer, metastasis, PULSAR, non small cell lung cancer, NSCLC

Sites: UT Southwestern; Parkland Health & Hospital System

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

Description:

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Hans Hammers

Gender: ALL

Age: 18 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06708949

IRB Number: STU20251028

Show full eligibility criteria

Inclusion Criteria:

• Willing and able to provide a signed and dated written informed consent.
• ≥ 18 years of age
• Confirmed diagnosis of RCC with a clear cell component
• Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
• No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed.
• Karnofsky performance status ≥ 70%.
• At least one measurable lesion as defined by RECIST 1.1 (Appendix 3) • A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion
• Adequate organ function within 28 days prior to first dose of protocol-indicated treatment, including: * White blood cell (WBC) ≥ 2,000 /µL * Absolute neutrophil count (ANC) ≥ 1,500/µL * Platelets ≥ 100,000/µL * Serum creatinine \< 1.5 x upper limit of normal (ULN) or creatinine clearance \> 30 mL/min (measured or calculated by Cockroft-Gault formula) * Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who must have total bilirubin \< 3.0 mg/dL) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN
• Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to receiving first dose of protocol-indicated treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. * "Women of childbearing potential" (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. * Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes. * If menopausal status is considered for the purpose of evaluating childbearing potential, women \< 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential.
• Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception Appendix 5 from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.

Exclusion Criteria:

• Prior systemic treatment for RCC of any type including neoadjuvant or adjuvant therapy is not allowed.
• ≤ 28 days before first dose of protocol-indicated treatment: • Major surgery requiring general anesthesia.
• ≤ 14 days before first dose of protocol-indicated treatment: * Radiosurgery or radiotherapy * Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery) * Active infection requiring infusion treatment.
• Any history of or current CNS metastases
• Any condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment. • In the absence of active autoimmune disease, subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhalational) ≤ 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg/day prednisone or equivalent daily (e.g. hormone replacement therapy needed in patients with hypophysitis)
• Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies). • Subjects with type I diabetes mellitus; endocrine organ dysfunction (e.g., hypothyroidism) that are controlled and only requiring only hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll.
• Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.
• History of myocarditis, regardless of etiology
• Troponin T (TnT) or I (TnI) \> 2× institutional upper limit of normal (ULN) • Participants with TnT or TnI levels between \> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. If TnT or TnI levels are between \> 1× to 2× ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \< 2× ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator.
• Treatment with any live/attenuated vaccine within 30 days of first study treatment

Interventions: DRUG: Drugs Nivolumab, DRUG: Ipilimumab, DRUG: BMS-986213 (Relatlimab-Nivolumab FDC)

Conditions: Renal Cell Carcinoma, Clear Cell, Kidney

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Digoxin Medulloblastoma Study

Description:

The purpose of this study is to evaluate the efficacy of digoxin in treating relapsed non-SHH, non-WNT medulloblastoma in pediatric and young adult patients.

Contact(s):

studyfinder@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age: 12 Months to 30 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06701812

Show full eligibility criteria

Inclusion Criteria:

* Patients must be age \>12 months and \<30 years at the time of enrollment. * Patients must have relapsed non-WNT, non-SHH medulloblastoma confirmed by a CAP/CLIA certified assay (such as nanostring or methylation) performed on tissue from diagnosis or relapse. * Patients must have received at least one prior course of chemotherapy for their medulloblastoma. They must also have received irradiation. * Prior therapy: Therapy may not have been received more recently than the timeframes defined below: Craniospinal radiotherapy: At least 3 months have elapsed since prior craniospinal radiotherapy (at doses ≥ 18 Gy). Local radiotherapy: At least 3 months since prior local radiotherapy to primary tumor. Focal radiotherapy: At least 2 weeks since prior focal radiotherapy to symptomatic metastatic sites. Myelosuppressive chemotherapy and/or immunotherapy and/or biologics: More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas), immunotherapy, or biologics. Hematopoietic growth factor: Seven days must have elapsed since the completion of therapy with colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or erythropoietin), or platelet-stimulating agents. * Patients must have recovered from any surgical procedures such as biopsy, with neurological stability for \> 7 days. * Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on MRI (ie, largest tumor diameter and its largest perpendicular). The size of a measurable lesion at baseline should be at least 2 times the thickness of the slices showing the tumor (adding the interslice gap). * Patients must have a Lansky or Karnofsky performance status score of ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky for patients \< 16 years of age. Patients who are unable to ambulate but who are functional in a wheelchair will be considered ambulatory for the purpose of assessing the performance score. * Patients must have normal organ and marrow function. * Patient has no evidence of Wolff-Parkinson-White syndrome or high-grade AV block (form of second-degree heart block) on screening ECG. * Patient has no evidence of hypertrophic obstructive cardiomyopathy on screening echo. * Any patient that reports recent palpitations (within the last month), or concerning findings on echo or ECG must be evaluated and cleared for treatment with digoxin by a cardiologist prior to enrollment. Study PI should be contacted for additional questions/concerns regarding these patients. * Patients receiving concurrent dexamethasone are eligible, provided dosage is stable or decreasing for ≥7 days prior to study enrollment. * Patients must have a stable neurologic status for ≥7 days prior to study enrollment. If a patient experiences neurologic decline following enrollment but prior to day 1 of cycle 1, they should be reassessed for eligibility. * Pregnancy: Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Female patients who are lactating must agree to stop breastfeeding. * Women of child-bearing 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 she or her partner is participating in this study, she should inform her treating physician immediately. * All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

* Participants who are receiving concurrent anticancer or any other investigational agents are ineligible. * Participants taking digoxin for any reason during treatment for initial diagnosis of medulloblastoma or relapse are ineligible. Exposure to digoxin therapy prior to initial diagnosis of medulloblastoma is allowed. * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to digoxin are ineligible. * Patients with serious or inadequately controlled cardiac arrhythmias, including baseline ectopy, ventricular tachycardia, frequent premature ventricular contractions (PVCs), or symptomatic sinus bradycardia are excluded from the study. * Patients taking medications that are known to interfere with digoxin metabolism are ineligible. * Participants with uncontrolled intercurrent illness, concurrent clinically significant unrelated systemic illness (e.g. serious infection) or significant cardiac, pulmonary, hepatic, or other organ dysfunction that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results are ineligible. * Participants with psychiatric illness/social situations that would limit compliance with study requirements are ineligible. * Pregnant women or women unwilling to stop breastfeeding are excluded from this study because it is unknown how pregnant women with recurrent medulloblastoma will metabolize and tolerate digoxin. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with digoxin in this setting. * Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Interventions: DRUG: Digoxin

Conditions: Medulloblastoma, Medulloblastoma, Non-WNT/Non-SHH

I'm interested

Share via email

See this study on ClinicalTrials.gov

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Description:

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Kevin Courtney

Gender: MALE

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06691984

IRB Number: STU20250143

Show full eligibility criteria

Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study-specific activities/procedures. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. * mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days prior to enrollment. * Evidence of progressive disease, defined as 1 or more PCWG3 criteria: * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL. * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. * Progression of bone disease: defined by the appearance of at least 2 new bone lesion(s) by bone scan (as per the 2+2 PCWG3 criteria). * Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide). * Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. * Adequate organ function. * Life expectancy of ≥ 12 weeks per the treating physician's assessment. Key

Exclusion Criteria:

Prior \& Concomitant Therapy: * Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen receptor pathway inhibitors (ARPIs) (abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment and androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]). * Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of study treatment unless participants received \< 2 cycles of therapy. * Prior palliative radiotherapy within 2 weeks of first dose of study treatment. Participants must have recovered from all radiation-related toxicities. * Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment. * Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment. * Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. Disease Related: * Participants with a history of central nervous system (CNS) metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible. * Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE version 5.0 events grade above 1 or baseline, with the exception of alopecia or toxicities that are stable and well controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.

Interventions: DRUG: Xaluritamig, DRUG: Abiraterone, DRUG: Enzalutamide, DRUG: Cabazitaxel

Conditions: Metastatic Castration-resistant Prostate Cancer, Prostate

Keywords: Oncology, Xaluritamig, Cabazitaxel, Prostate cancer, Abiraterone, Enzalutamide

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (TRANSCEND)

Description:

In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is: • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year * How many people have no blood vessel inflammation at these times * Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment * Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year * Changes in kidney function from the start of treatment * How many people have biopsy results showing their kidney tissue looks normal again * How long the transplanted kidney keeps working * How many participants have medical problems during the study * How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52 * How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time * How felzartamab is processed by the body * How many participants develop antibodies against felzartamab in the blood The study will be done as follows: * Participants will be screened to check if they can join the study. This will take up to 42 days. * There will be 2 parts in this study. * Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo. * Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab. * All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight. * Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Elaine.Bonilla@UTSouthwestern.edu

Principal Investigator: David Wojciechowski

Gender: ALL

Age: 18 Years to 75 Years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06685757

IRB Number: STU20250439

Show full eligibility criteria

Interventions: DRUG: Felzartamab, DRUG: Placebo

Conditions: Antibody-mediated Rejection

Keywords: AMR, Felzartamab, Kidney Transplant

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS)

Description:

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Sawsan Rashdan

Gender: ALL

Age: 18 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06667076

IRB Number: STU-2024-1175

Show full eligibility criteria

Inclusion Criteria:

* Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy * Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended * Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated * Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement) * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis * Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing) * Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study * Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Interventions: DRUG: Amivantamab, DRUG: Lazertinib, DRUG: Chemotherapy: Pemetrexed, DRUG: Chemotherapy: Carboplatin

Conditions: Carcinoma, Non-Small-Cell Lung, Lung/Thoracic

Sites: UT Southwestern; Parkland Health & Hospital System

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Phase 2 Basket Study of Vosoritide in Children With Turner Syndrome, SHOX Deficiency and Noonan Syndrome With an Inadequate Response to Human Growth Hormone

Description:

The purpose of this basket study in children with Turner syndrome, SHOX deficiency, and Noonan syndrome is to evaluate the effect of 3 doses of vosoritide versus hGH on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, colten.youngblood@childrens.com

Principal Investigator: Nadia Merchant

Gender: ALL

Age: 3 Years to 11 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06668805

IRB Number: STU-2024-0821

Show full eligibility criteria

Inclusion Criteria:

• Participants must be ≥ 3 years old, and \< 11 years old (females) or \< 12 years old (males), at the time of signing the informed consent form
• A genetically confirmed diagnosis of Turner syndrome, SHOX deficiency or Noonan syndrome.
• A height assessment corresponding to a height Z-score of \> -2.00 SDs and ≤ -1.75 SDs (up to 20% of participants)/≤ -2.00 SDs (at least 80% of participants) in reference to the general population of the same age and sex.
• Tanner Stage 1, at time of signing the ICF.
• Have been receiving continuous hGH for the treatment of short stature associated with their condition for a minimum of 1 year immediately prior to enrollment and be receiving a dose of ≥ 0.35 mg/kg weekly, with no weight-based dosing changes in the last 6 months and none planned in the future.
• Are willing to continue on hGH at their current dose for the Baseline Growth Phase, and for 2 years post randomization if randomized to the hGH arm.
• Inadequate response to prior hGH treatment.

Exclusion Criteria:

• Participants with Turner syndrome known to have Y-chromosome material unless they have undergone gonadectomy and have fully external female genitalia.
• Diagnosis of systemic disease or condition that may cause short stature other than Turner syndrome, SHOX deficiency, or Noonan syndrome, eg, renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease.
• Bone age advanced beyond chronological age by more than 2 years.
• Uncorrected congenital heart disease which places the participant at increased risk of an adverse cardiac outcome in the setting of hypotension,
• Have an unstable condition likely to require surgical intervention during the study.
• Evidence of decreased growth velocity (AGV \< 1.5 cm/year) as assessed over a period of at least 6 months and growth plate closure assessed using bilateral lower extremity X-rays.
• Previous limb-lengthening surgery, or planned or expected to have limb lengthening surgery during the study period.
• Planned or expected bone-related surgery (ie, surgery involving disruption of bone cortex, excluding tooth extraction), during the study period.

Interventions: DRUG: Vosoritide Injection, DRUG: Human Growth Hormone

Conditions: Short Stature Homeobox- Containing Gene SHOX Deficiency, Noonan Syndrome, Turner Syndrome

Keywords: Short Stature, Musculoskeletal Diseases, Bone Diseases, Developmental Endocrine System Diseases Natriuretic Peptide, C-Type

Sites: Children’s Health

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2)

Description:

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Syed Kazmi

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06662786

IRB Number: STU20240010

Show full eligibility criteria

Interventions: BIOLOGICAL: Amivantamab, BIOLOGICAL: Cetuximab, DRUG: 5-fluorouracil, DRUG: Leucovorin calcium/Levoleucovorin, DRUG: Oxaliplatin, DRUG: Irinotecan Hydrochloride

Conditions: Colorectal Neoplasms, Colon, Rectum

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

Description:

This will be a prospective single-center interventional trial to compare the outcomes of HIV-positive heart transplant recipients by the HIV status of the donor; HIV-positive vs. HIV-negative and learn whether heart organ transplantation from HIV+ deceased donors is as safe and effective in HIV+ recipients as transplants from HIV- deceased donors. Patient will undergo standard evaluation for eligibility of transplantation by the primary heart transplant team. If patient meets eligibility criteria, they will be informed about the study and consent will be obtained. Informed consent will be obtained in a private clinic or inpatient hospital room in a confidential setting. HIV-positive or HIV-negative offers will be made by Organ Procurement and Transplantation Network (OPTN) (serving as a means of "natural randomization" and this information will also be collected, along with the information regarding any information for primary offer declines from the patients as well as other clinical indications to decline an organ offer. As a result of this, there will be two main groups in the study participants that will undergo analysis: 1. patients/recipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+/R+ group) 2. patients/recipients that are HIV+ who receive an organ from an HIV negative donor (HIV D-/R+ group) Only study participants will be able to receive organ offers from both HIV-positive and HIV-negative organ donors whichever is available first regardless of HIV status. This is the only study intervention. Baseline visit parameters will be obtained during a routine heart transplant visit. There will be no additional procedures or blood collection after the baseline study visit. Study data will be collected from chart review of routine post-transplant follow-up visits at weeks 52 (1 year), 104 (2 years), and 152 (3 years) after the transplant.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Ricardo.LaHoz@UTSouthwestern.edu

Principal Investigator: Ricardo La Hoz

Gender: ALL

Age: 18 Years to old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06659952

IRB Number: STU-2024-0777

Show full eligibility criteria

Inclusion Criteria:

All individuals with advanced heart failure and HIV infection who meet the study inclusion and exclusion criteria will be eligible for participation in the study. * Participant meets the standard criteria for heart transplant at the local center. * Participant is able to understand and provide informed consent. * Participant meets with an independent advocate per the HOPE Act Safeguards and Research Criteria. * Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).\* * Participant is ≥ 18 years old. * Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.\* * CD4+ (cluster of differentiation 4+) T-cell count: ≥ 200/μL within 16 weeks of transplant.\* * HIV-1 RNA is below 50 copies RNA/mL.\*/\*\* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. \*\*Organ recipients who are unable to tolerate ART due to organ failure or recently started Antiretroviral Therapy (ART) may have detectable viral load and still be eligible if a safe and effective antiretroviral regimen to be used by the recipient after transplantation is described. * Participant is willing to comply with all medications related to their transplant and HIV management. * For participants with a history of aspergillus colonization or disease, no evidence of active disease. * The participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management. * Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until after study completion. * Participant is not suffering from significant wasting (e.g. body mass index \< 21) thought to be related to HIV disease.

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants: * Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.\* * Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.) * Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Interventions: OTHER: HIV-positive heart transplant

Conditions: HIV Infection, Advanced End Stage Heart Failure

Keywords: HIV positive donor, HIV positive recipient, Heart transplant

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma

Description:

This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB. Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor. The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Avanthi Shah

Gender: ALL

Age: to 21 Years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06647953

IRB Number: STU20250654

Show full eligibility criteria

Inclusion Criteria:

* 21 years of age or younger * Newly diagnosed PPB. Note that patients with known germline DICER1 variant or mosaicism with a large, solid unresectable thoracic mass with imaging features characteristic for Type II or III PPB are eligible without histologic confirmation of the diagnosis if a biopsy of the mass is not considered safe or feasible * Individuals are eligible based on institutional diagnosis of Type I, Ir, II or III PPB diagnosed within 60 days prior to enrollment. Children with Type II or III PPB at risk for clinical decompensation may receive protocol therapy while awaiting rapid central pathology review. Children with Type I or Ir PPB will be assigned to chemotherapy vs. observation based on imaging and central pathology review diagnosis. Type I and Ir patients should not begin chemotherapy prior to return of central pathology results * For patients with Type II or III PPB (within 7 days prior to enrollment): A serum creatinine based on age/sex as follows: * Age: 1 month to \< 6 months - Maximum Serum Creatinine (mg/dL): 0.4 (Male), 0.4 (Female) * Age: 6 months to \< 1 year - Maximum Serum Creatinine (mg/dL): 0.5 (Male), 0.5 (Female) * Age: 1 to \< 2 years - Maximum Serum Creatinine (mg/dL): 0.6 (Male), 0.6 (Female) * Age: 2 to \< 6 years - Maximum Serum Creatinine (mg/dL): 0.8 (Male), 0.8 (Female) * Age: 6 to \< 10 years - Maximum Serum Creatinine (mg/dL): 1 (Male), 1 (Female) * Age: 10 to \< 13 years - Maximum Serum Creatinine (mg/dL): 1.2 (Male), 1.2 (Female) * Age: 13 to \< 16 years - Maximum Serum Creatinine (mg/dL): 1.5 (Male), 1.4 (Female) * Age: ≥ 16 years - Maximum Serum Creatinine (mg/dL): 1.7 (Male), 1.4 (Female) OR - A 24 hour urine creatinine clearance ≥ 60 mL/min/1.73 m\^2 OR - A glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard) * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility * For patients with Type II or III PPB (within 7 days prior to enrollment): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age * For patients with Type II or III PPB (within 7 days prior to enrollment): Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) ≤ 135 U/L * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram (within 21 days prior to start of protocol therapy) * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4

Exclusion Criteria:

* Administration of prior PPB-directed chemotherapy is an exclusion criterion. Prior treatment for another malignancy is not an exclusion criterion * Patients with known Charcot-Marie-Tooth disease * 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 * 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

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, BIOLOGICAL: Dactinomycin, DRUG: Dexrazoxane, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, DRUG: Ifosfamide, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, OTHER: Patient Observation, PROCEDURE: Positron Emission Tomography, DRUG: Topotecan, PROCEDURE: Ultrasound Imaging, DRUG: Vincristine

Conditions: Pleuropulmonary Blastoma, Lung/Thoracic

Sites: Children’s Health

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria

Description:

The goal of this Phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adolescents (12 to less than 18 years of age) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 4 in 5 (or 80%) chance of receiving JNT-517. The study will last for up to 63 days including a Screening period, Treatment period and Follow-up period for safety. Participants will: * Take 75 mg JNT-517 or a placebo BID (2x per day) for 28 days * Visit the clinic or have a mobile health nurse visit your home for checkups and tests * Collect urine sample at home and bring to clinic on specified days * Keep a food diary 3 days before each study visit

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Juana.Luevano@UTSouthwestern.edu

Principal Investigator: Markey McNutt

Gender: ALL

Age: 12 Years to 17 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06637514

IRB Number: STU20240016

Show full eligibility criteria

Key

Inclusion Criteria:

• Males and females 12 to less than 18 years of age, inclusive on Day 1.
• Clinical diagnosis of PKU.
• Ability to swallow tablets.
• Average of 2 plasma Phe levels during the Screening period greater than 360 μM and no plasma Phe level less than 300 μM.
• Body weight equal or greater than 45 kg and body mass index less than 40 kg/m2.
• Females of childbearing potential must practice sexual abstinence or agree to use 2 highly effective contraceptive methods.
• Capable of giving signed informed consent (emancipated minors) or parent/legal guardian to provide informed consent and the participant to give assent and confirm ability to comply with study procedures. Key

Exclusion Criteria:

• Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.
• Positive for hepatitis B or C or human immunodeficiency virus.
• Any history of malignancy in the last 5 years, excluding nonmelanoma skin cancer.
• Any history of liver disease.
• Any history of cataracts or more than minimal cataracts observed during the Screening ophthalmologic examination.
• Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
• Creatinine clearance less than 90 mL/min by Cockcroft-Gault formula.
• History of drug or alcohol abuse in the last year
• Current, recent, or suspected infection within 14 days of Screening of SARS CoV 2/COVID 19.
• Participation in another investigational drug trial within 30 days or, if known 5 half-lives of investigational drug (whichever is longer).
• Unable to tolerate oral medication.
• Allergy to JNT-517 or any component of the investigational product.
• Received greater than 50 mL of blood or plasma within 30 days of Screening or greater than 500 mL of blood or plasma within 60 days of Screening.

Interventions: DRUG: JNT-517 Tablet, OTHER: Placebo, DRUG: JNT-517 Tablet

Conditions: Phenylketonuria (PKU), Other Endocrine System

Keywords: PKU

Sites: UT Southwestern; Children’s Health

I'm interested

Share via email

See this study on ClinicalTrials.gov

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Description:

A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Yazan Madanat

Gender: ALL

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06634394

IRB Number: STU-2024-1192

Show full eligibility criteria

Inclusion Criteria:

* 1. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated.
• Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable.
• Patient must be considered ineligible for induction therapy defined by at least one of the following:
• ≥75 years of age
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
• Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
• Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
• Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular
• Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks

Exclusion Criteria:

• Patient has received treatment with the following:
• A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
• CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
• Experimental therapies for MDS or AML
• Patient is currently participating in another interventional research study.
• Patient has history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
• Patient has acute promyelocytic leukemia.
• Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy \>10 mg methylprednisolone daily or its equivalent
• Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose).
• Patient has known active CNS involvement with AML. Patients who received intrathecal chemotherapy for prophylaxis of AML in the CNS prior to enrollment may enroll in this study.
• Creatinine clearance \<30ml/min based on Cockcroft-Gault or MDRD formular.
• Bilirubin of \>3xULN in the absence of Gilbert's Syndrome.
• AST and/or ALT \>3 times the ULN.

Interventions: DRUG: APVO436, DRUG: Venetoclax, DRUG: Azacitidine

Conditions: Acute Myeloid Leukemia (AML), Myeloid and Monocytic Leukemia

Keywords: Acute Myeloid Leukemia

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Neonatal Platelet Transfusion Threshold Trial (NeoPlaTT)

Description:

The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Arpineh.Chavez@UTSouthwestern.edu

Principal Investigator: Vishal Kapadia

Gender: ALL

Age: 1 Hour to 48 Hours old

Phase: NA

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06676904

IRB Number: STU20250417

Show full eligibility criteria

Interventions: PROCEDURE: Higher Platelet Transfusion Threshold, PROCEDURE: Lower Platelet Transfusion Threshold

Conditions: Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Thrombosis

Keywords: platelet transfusion, neonatal, thrombosis

Sites: UT Southwestern; Children’s Health; Parkland Health & Hospital System

I'm interested

Share via email

See this study on ClinicalTrials.gov

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Description:

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Nisha Unni

Gender: ALL

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06625775

IRB Number: STU20250194

Show full eligibility criteria

Inclusion Criteria:

* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC) * Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only) * Stable brain metastases * Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC) * Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy * BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i * BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted * BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required

Exclusion Criteria:

* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors * Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2) * Patients with untreated and/or non-stable brain metastases Other inclusion/exclusion criteria are specified in the protocol

Interventions: DRUG: BBO-10203, DRUG: Trastuzumab, DRUG: Fulvestrant, DRUG: Ribociclib, DRUG: FOLFOX, DRUG: Bevacizumab

Conditions: Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors, HER2-positive Metastatic Breast Cancer, KRAS Mutant Metastatic Colorectal Cancer, Metastatic Lung Cancer, Metastatic Colorectal Cancer, Advanced Lung Cancer, HR-positive, HER2-negative Advanced Breast Cancer, HER2-positive Advanced Breast Cancer, Breast - Female, Breast - Male, Colon, Lung/Thoracic, Rectum

Keywords: BREAKER-101, BridgeBio Oncology Therapeutics, BBOT, Phase1, Phase 1a/1b, Trastuzumab, Breast, Colorectal, Non-Small Cell Lung Cancer, CRC, NSCLC, Metastatic Cancer, Advanced Cancer, HER2-positive, HR-positive, HR-positive, HER2-negative, HER2-negative

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (PREDICT)

Description:

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Joseph Vento

Gender: ALL

Age: 18 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06632977

IRB Number: STU20251212

Show full eligibility criteria

Inclusion Criteria:

* PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required. * PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1. * PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated. * PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review. * PRE-REGISTRATION: Age ≥ 18 years. * REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply): * PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy. * Radiographic progression per RECIST 1.1 criteria for soft tissue lesions * Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria. * REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis). * REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi. * REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of: * Chemotherapy-induced neuropathy * Fatigue * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo) * REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration. * REGISTRATION: No major surgery within 4 weeks of registration. * REGISTRATION: No prior treatment with EZH inhibitors. * REGISTRATION: Prior treatment with cabazitaxel + carboplatin. * REGISTRATION: None of the following conditions: * Current use of moderate or strong cytochrome P450 (CYP)3A inducers. * Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. \* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Imminent or established spinal cord compression based on clinical and/or imaging findings. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration. * Significant cardiovascular defined as: * Myocardial infarction within 6 months prior to enrollment. * Uncontrolled angina pectoris within 6 months prior to enrollment. * New York Heart Association Class 3 or 4 congestive heart failure. * Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG. * Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg). * Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy. * Moderate to severe hepatic impairment (Child-Pugh Class C) * REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration. * REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration. * REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration. * REGISTRATION: No platelet transfusions within 2 weeks of registration. * REGISTRATION: No bleeding diathesis. * REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL. * REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL. * REGISTRATION: Hemoglobin ≥ 9 g/dL. * REGISTRATION: Platelet count ≥ 100,000/mcL. * REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation. * REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \[ULN\] for subjects with documented Gilbert\'s disease). * REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN. * REGISTRATION: Albumin ≥ 2.8 g/dL. * REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org. * RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration). * RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of: * Chemotherapy-induced neuropathy * Fatigue * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo). * RE-REGISTRATION: None of the following conditions: * Imminent or established spinal cord compression based on clinical and/or imaging findings. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration. * Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. * Significant cardiovascular defined as: * Myocardial infarction within 6 months prior to enrollment. * Uncontrolled angina pectoris within 6 months prior to enrollment. * New York Heart Association Class 3 or 4 congestive heart failure. * Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg). * RE-REGISTRATION: ECOG Performance Status 0-2. * RE-REGISTRATION: No GCSF within 2 weeks of registration. * RE-REGISTRATION: No RBC transfusions within 2 weeks of registration. * RE-REGISTRATION: No platelet transfusions within 2 weeks of registration. * RE-REGISTRATION: WBC ≥ 2,500/mcL. * RE-REGISTRATION: ANC ≥ 1,500/mcL. * RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted). * RE-REGISTRATION: Platelet count ≥ 100,000/mcL. * RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation. * RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease). * RE-REGISTRATION: AST and ALT ≤ 3 x ULN. * RE-REGISTRATION: Albumin ≥ 2.8 g/dL. * RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF). * RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.

Exclusion Criteria:

\-

Interventions: OTHER: Genetic testing, DRUG: Valemetostat Tosylate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Computed Tomography, PROCEDURE: Bone scan, PROCEDURE: FDG-Positron Emission Tomography, PROCEDURE: PSMA PET Scan, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cabazitaxel, DRUG: Abiraterone Acetate, DRUG: Enzalutamide, DRUG: Lutetium Lu 177 Vipivotide Tetraxetan

Conditions: Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Prostate

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Description:

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Contact(s):

studyfinder@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age: 60 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06635148

Show full eligibility criteria

Interventions: DRUG: JNJ-81201887, OTHER: Sham Procedure

Conditions: Geographic Atrophy, Macular Degeneration

I'm interested

Share via email

See this study on ClinicalTrials.gov

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (RAINFOL-02)

Description:

This phase 3 study will be conducted in different countries all over the world. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Jayanthi Lea

Gender: FEMALE

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06619236

IRB Number: STU20250047

Show full eligibility criteria

Key

Inclusion Criteria:

* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. * Participants may be enrolled regardless of FRα expression level. * Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy. * Participants must have received prior treatment with the following therapies: * Platinum chemotherapy * Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance * Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor * Mirvetuximab soravtansine, if: * Mirvetuximab soravtansine is available in the enrollment region, and * The participant is eligible based on positive FRα expression per Food and Drug Administration (FDA)-approved (or local equivalent) test, and * The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision. * Participants must have platinum-resistant disease: * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \> 91 days and ≤ 183 days after the date of the last dose of platinum. * Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum. Key

Exclusion Criteria:

* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor. * Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen. * History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer. * Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry. * Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility. * Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management. Enrollment of participants with an indwelling peritoneal catheter must be discussed with the medical monitor to determine eligibility. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Interventions: DRUG: Rina-S, DRUG: Paclitaxel, DRUG: Topotecan, DRUG: Pegylated liposomal doxorubicin (PLD), DRUG: Gemcitabine

Conditions: Platinum-resistant Ovarian Cancer, Ovary

Keywords: antibody-drug conjugate, folate receptor alpha (FRα), ovarian cancer, fallopian tube cancer, primary peritoneal cancer, folate receptor, platinum-resistant ovarian cancer (PROC), rinatabart sesutecan, Topoisomerase 1 inhibitor, PRO1184, GEN1184

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Description:

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Syed Kazmi

Gender: ALL

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06607185

IRB Number: STU-2024-1087

Show full eligibility criteria

Interventions: DRUG: LY4066434., DRUG: Cetuximab, DRUG: Nab paclitaxel, DRUG: Gemcitabine, DRUG: Oxaliplatin, DRUG: Leucovorin, DRUG: Irinotecan, DRUG: 5Fluorouracil, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: Pemetrexed, DRUG: Pembrolizumab

Conditions: Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Metastatic Solid Tumor, Anus, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Esophagus, Gall Bladder, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Urinary Bladder

Keywords: KRAS, KRAS mutation, KRASG12C, KRASG12D, KRASG12V, KRASG12S, KRASG12A, KRASG13D, LY4066434, Targeted therapy, Lung cancer, Pancreas cancer, Colon cancer, Rectal cancer, Colorectal cancer, Ovarian cancer, Endometrial cancer, Cholangiocarcinoma, Esophageal cancer, KRAS-mutant tumor

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

Description:

The purpose of this screening study is to accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeds in participants with Von Willebrand Disease (VWD). Data from this study will be used to establish baseline bleeding and treatment rates in a population of participants with VWD and act as comparator data for future clinical study outcomes.(e.g. Velora Pioneer)

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Ruth.Ikpefan@UTSouthwestern.edu

Principal Investigator: Yu-Min Shen

Gender: ALL

Age: 16 Years to old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06610201

IRB Number: STU20250392

Show full eligibility criteria

Interventions: OTHER: Clinical outcomes of patients with VWD, Type 1, OTHER: Clinical outcomes of patients with VWD, Type 2A, Type 2M, Type 2N, or Type 3

Conditions: Von Willebrand Disease (VWD), Von Willebrand Disease (VWD), Type 1, Von Willebrand Disease (VWD), Type 2, Von Willebrand Disease (VWD), Type 3, Von Willebrand Disease, Type 2A, Von Willebrand Disease, Type 2M, Von Willebrand Disease, Type 2N

Keywords: Von Willebrand Disease (VWD), Prospective Study, Type 1 VWD, Type 2 VWD, Type 3 VWD, Prophylaxis, Von Willebrand Factor (VWF)

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer (SPARK)

Description:

To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Raquibul Hannan

Gender: ALL

Age: 18 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06601296

IRB Number: STU-2024-0919

Show full eligibility criteria

Interventions: DRUG: IMSA101

Conditions: Metastatic Renal Cell Carcinoma ( mRCC), OligoProgressive Metastatic Disease, Kidney

Keywords: renal, kidney, mrcc, metastatic, cancer, STING, PULSAR, SABr, SPARK, nivolumab, IMSA 101

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (Ametrine-1)

Description:

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Luis.Madrigal@UTSouthwestern.edu

Principal Investigator: Moheb Boktor

Gender: ALL

Age: 16 Years to 80 Years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06589986

IRB Number: STU20250234

Show full eligibility criteria

Interventions: DRUG: Afimkibart, DRUG: Placebo

Conditions: Moderately to Severely Active Ulcerative Colitis

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

PREEMIE: Study for Treatment of PDA in Premature Infants (PREEMIE)

Description:

This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, wendy.rojas@childrens.com

Principal Investigator: Surendranath Veeram Reddy

Gender: ALL

Age: 5 Days to old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06587282

IRB Number: STU-2024-1162

Show full eligibility criteria

Interventions: DEVICE: Bloom Micro Occluder System

Conditions: Patent Ductus Arteriosus (PDA)

Sites: Children’s Health

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma (RP2-202)

Description:

The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Sanjay Chandrasekaran

Gender: ALL

Age:

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06581406

IRB Number: STU20240015

Show full eligibility criteria

Key

Inclusion Criteria:

* Patients who are 18 years of age or older at the time of signed informed consent. * Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection. * Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \[LN\]) that is amenable to serial RP2 injections. * Must be willing to provide tumor biopsy samples. * LDH ≤ 2 × upper limit of normal (ULN). * Has adequate hematologic, hepatic and renal function * Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \[INR\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Life expectancy of \> 6 months as estimated by the Investigator. Key

Exclusion Criteria:

* Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma. * Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection. * Current active significant herpetic infections or prior complications of HSV-1 infection. * Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis. * Major surgery ≤ 2 weeks prior to the first dose of study intervention. * Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy. * Active, known, or suspected autoimmune disease requiring systemic treatment. * Prior treatment with an oncolytic virus. * Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir). * Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose. * Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose. * Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment. Additional inclusion/ exclusion criteria are outlined in the study protocol

Interventions: BIOLOGICAL: RP2, BIOLOGICAL: Ipilimumab, BIOLOGICAL: Nivolumab

Conditions: Metastatic Uveal Melanoma, Melanoma, skin

Keywords: Metastatic, Uveal, Melanoma, Nivolumab, Ipilimumab, Randomized, Immune checkpoint inhibitor-naïve, RP2, Oncolytic viruses, HSV-1

Sites: UT Southwestern

I'm interested

Share via email

See this study on ClinicalTrials.gov

Search Results

Optical Coherence Tomography Angiography in Neurological Disease

Effect of the Stellate Ganglion Block on the Retinal Microcirculation

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy (OrigAMI-3)

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (SUPRAME)

Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 (P300)

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

Digoxin Medulloblastoma Study

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (TRANSCEND)

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS)

A Phase 2 Basket Study of Vosoritide in Children With Turner Syndrome, SHOX Deficiency and Noonan Syndrome With an Inadequate Response to Human Growth Hormone

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2)

HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma

A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Neonatal Platelet Transfusion Threshold Trial (NeoPlaTT)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (PREDICT)

A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (RAINFOL-02)

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer (SPARK)

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (Ametrine-1)

PREEMIE: Study for Treatment of PDA in Premature Infants (PREEMIE)

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma (RP2-202)

Email this study information to me

Contact the study team