UTSW - Study Finder

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

Description:

To evaluate progression of metastatic renal cell carcinoma from the initiation of PULSAR radiotherapy in combination with IMSA101 injectable onward.

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

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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

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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

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Interventions: DRUG: Afimkibart, DRUG: Placebo

Conditions: Moderately to Severely Active Ulcerative Colitis

Sites: UT Southwestern

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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

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Interventions: DEVICE: Bloom Micro Occluder System

Conditions: Patent Ductus Arteriosus (PDA)

Sites: Children’s Health

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The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity (TMSpine)

Description:

The goal of this project is to test our central hypothesis that the spinal cord neuroplasticity in females will be modulated by the level of estradiol concentration. under aim 1 we will determine the influence of estradiol fluctuations on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy females and males. We will use an established repetitive peripheral nerve electrical stimulation with a stimulation intensity below the motor threshold to prime the spinal motor circuits. under aim 2 we seek to characterize the input output property of spinal circuit excitability after descending drive (motor) mediated priming in young healthy male participants. in aim 3 we will examine the influence of estradiol fluctuations on descending drive mediated motor priming in young healthy females.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Yu-Chen.Chung@UTSouthwestern.edu

Principal Investigator: Yasin Dhaher

Gender: ALL

Age: 18 Years to 39 Years old

Phase:

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06656819

IRB Number: STU-2020-0738

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Interventions: DEVICE: Magstim Rapid2

Conditions: Healthy

Sites: UT Southwestern

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A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer

Description:

High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Nilesh Verma

Gender: ALL

Age: 18 Years to old

Phase: PHASE4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06562543

IRB Number: STU-2024-0987

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Inclusion Criteria:

• Provide written (or electronic) informed consent.
• Male or female aged more than or equal to (≥)18 years.
• Presence of histologically and/or cytologically documented metastatic colorectal adenocarcinoma. Rat sarcoma virus (RAS) status for each participant must be documented.
• Have been previously treated with standard approved therapies: * Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, * An anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., bevacizumab, aflibercept, ramucirumab \[regorafenib is NOT an anti-VEGF biologic\]), and * If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab). * If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor.
• Self-identify as Black and/or African American or Hispanic and/or Latino or as both.
• Body weight ≥40 kilograms (kg).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.
• Have assessable disease according to RECIST version 1.1, assessed locally.
• In participants of childbearing potential, agreement to use highly effective form(s) of contraception, which results in a low failure rate (less than \[\<\]1 percent \[%\] per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire trial period, and for 2 weeks after taking the last dose of the trial intervention. Such methods include oral (PO) hormonal contraception (combined estrogen/progestogen or progestogen-only) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Those assigned male sex at birth must always use a condom.

Exclusion Criteria:

• Absolute neutrophil count (ANC) \<1.5 times 10\^9 per liter (10\^9/L), platelet count \<100 times 10\^9/L, or hemoglobin \<9.0 grams per deciliter (g/dL). Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed.
• Serum total bilirubin more than (\>)1.5 times the upper limit of normal range (ULN). Participants with previously documented Gilbert syndrome and bilirubin \<2 times ULN are eligible.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times ULN in participants without hepatic metastases; ALT or AST \>5 times ULN in participants with hepatic metastases.
• Creatinine clearance \<30 milliliters per minute (mL/min). Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation. Where available and appropriate, other formulae may be used to estimate clearance after consultation with the trial medical monitor.
• Urine dipstick or urinalysis with protein ≥2 positive or 24-hour urine protein ≥1.0 gram per 24 hours (g/24 hours). Participants with 1+ positive proteinuria must undergo a 24-hour urine collection to assess urine protein level.
• Uncontrolled hypertension, defined as systolic BP ≥140 millimeter of mercury (mmHg) and/or diastolic blood pressure (BP) ≥90 mmHg despite optimal medical management. The participant must have BP below both limits. Repeated assessments are permitted.
• International normalized ratio (INR) \>1.5 times ULN or activated partial thromboplastin time (aPTT) \>1.5 times ULN, unless the participant is currently receiving or intended to receive anticoagulants for prophylactic purposes.
• History of or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation within the 6 months prior to screening.
• History or presence of hemorrhage from any other site (e.g, hemoptysis or hematemesis) within 2 months prior to screening.
• History of a thromboembolic event, including deep vein thrombosis, pulmonary embolism, or arterial embolism within 6 months prior to screening.
• Stroke and/or transient ischemic attack within 12 months prior to screening.
• Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction \<50% by echocardiogram.
• QT interval, corrected using the Fridericia method (QTcF) \>480 milliseconds or any factors that increase the risk of QT interval, corrected based on the patient's heart rate (QTc) prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, or family history of long QT syndrome.
• Systemic antineoplastic therapies (except for that described in exclusion criterion no. 15) or any investigational therapy within 2 weeks prior to the first dose of the trial intervention, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy.
• Systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors \[TKIs\]) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of the trial intervention.
• Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of the trial intervention.
• Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of the trial intervention.
• Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 14 days prior to the first dose of the trial intervention or unhealed surgical incision.
• Any unresolved toxicities from previous antitumor treatments greater than NCI CTCAE, version 5.0, Grade 1 (except for alopecia or neurotoxicity Grade less than or equal to \[≤\]2).
• Known human immunodeficiency virus infection.
• Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load had to be undetectable on suppressive therapy, if indicated. Participants with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
• Clinically uncontrolled active infection requiring intravenous (IV) antibiotics.
• Tumor invasion of a large vascular structure (e.g., pulmonary artery or superior or inferior vena cava).
• Those who are currently pregnant or lactating.
• Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; participants requiring steroids within 4 weeks prior to the start of the trial intervention are to be excluded.
• Other malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or bladder carcinoma (tumor in situ and T1) that had been adequately treated during the 5 years prior to screening. Participants with another primary malignancy that has been adequately treated may be included after consultation with the trial medical monitor.
• Inability to take medication PO, dysphagia, or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe might affect absorption of the investigational medicinal product (IMP).
• Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect might prohibit use of the IMP, affect interpretation of trial results, or put the participant at undue risk of harm based on the investigator's assessment.
• Known hypersensitivity to fruquintinib or any of its inactive ingredients, including the azo dyes Tartrazine- Federal Food, Drug, and Cosmetic Act (FD\&C) Yellow 5 and Sunset yellow For Coloring Food (FCF)-FD\&C Yellow 6.
• Received prior fruquintinib.
• Live vaccine ≤28 days before the first dose of the trial intervention. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
• Use of strong inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose of the trial intervention.

Interventions: DRUG: Fruquintinib

Conditions: Colorectal Cancer, Colon, Rectum

Keywords: colorectal cancer, fruquintinib

Sites: UT Southwestern

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Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Description:

The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Kevin Courtney

Gender: MALE

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06555796

IRB Number: STU-2024-0958

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Inclusion Criteria * Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. * Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent. * PSA doubling time ≤ 12 months. * Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT. * Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer. * Serum testosterone ≥ 150 ng/dL (5.2 nmol/L). * Participants must have undergone a prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during or within 3 months of screening. Exclusion Criteria * Present evidence of metastatic disease in conventional CT scan and/or bone scan * Participants that present PSMA-positive lesions in the PSMA PET scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease. * Prior hormonal therapy, exceptions include: * Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or * A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment. * Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer. * Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment. * Prior systemic biologic therapy, including immunotherapy, for prostate cancer. * If, in the investigator's opinion, salvage therapy is the preferred intervention. * Autoimmune disease requiring systemic immunosuppression within the past 2 years. * Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment. * Requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[TNFα\] therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.

Interventions: DRUG: Xaluritamig

Conditions: Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer, Prostate

Keywords: Xaluritamig, T-Cell Engager, AMG509, STEAP1, Immunotherapy

Sites: UT Southwestern

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A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy (SIENNA)

Description:

This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Juan.Mo@UTSouthwestern.edu

Principal Investigator: Yu-Guang He

Gender: ALL

Age: 50 Years to 85 Years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06541704

IRB Number: STU-2024-0904

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Key

Inclusion Criteria:

• Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
• Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
• BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
• Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
• Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol Key

Exclusion Criteria:

• GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
• History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
• Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization
• Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization
• Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study
• Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol Systemic Exclusion criteria
• History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
• History of solid organ or bone marrow transplantation
• Use of chronic (\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
• Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol
• Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
• Carrier of Neisseria meningitidis based on culture collected during screening
• Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Interventions: DRUG: Pozelimab, DRUG: Cemdisiran, DRUG: Placebo

Conditions: Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)

Keywords: GA secondary to AMD

Sites: UT Southwestern

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Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

Description:

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Ksenya Shliakhtsitsava

Gender: FEMALE

Age: to 39 Years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06513962

IRB Number: STU20250281

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Inclusion Criteria:

* \< 40 years of age at the time of enrollment * Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.) * Newly diagnosed with first cancer, exclusive of breast cancer. * Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma). * Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard. * For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria:

* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI). * Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged). * Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc. * Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions. * Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period. * Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment. * Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI). * Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential. * Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose). * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

Interventions: OTHER: Best Practice, PROCEDURE: Biospecimen Collection, OTHER: Electronic Health Record Review, OTHER: Survey Administration, DRUG: Triptorelin Pamoate

Conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

Sites: UT Southwestern; Children’s Health

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Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26) (ASCENT-GYN-01)

Description:

The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC). The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).

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: NCT06486441

IRB Number: STU-2024-0865

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Interventions: DRUG: Sacituzumab govitecan-hziy, DRUG: Doxorubicin, DRUG: Paclitaxel

Conditions: Endometrial Cancer, Corpus Uteri

Sites: UT Southwestern

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Registry for Stage 2 Type 1 Diabetes

Description:

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

Contact(s):

studyfinder@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age:

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06481904

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Interventions: DRUG: TZIELD (teplizumab-mzwv)

Conditions: Type 1 Diabetes

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A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Description:

This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. Since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, vidiya.srikakulapu@UTSouthwestern.edu

Principal Investigator: Jonathan Whittamore

Gender: ALL

Age: 18 Years to 99 Years old

Phase: PHASE4

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT06481150

IRB Number: STU-2023-1257

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Interventions: DRUG: Tenapanor, OTHER: Placebo

Conditions: Hyperoxaluria

Sites: UT Southwestern

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Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

Description:

To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: David Sher

Gender: ALL

Age: 18 Years to 99 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06477692

IRB Number: STU-2024-0603

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Inclusion Criteria:

* Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed. * Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (≤ 2 nodes) is also allowable. * Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer. * Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded * Age ≥ 18 years. * ECOG Performance Status 0-2 * All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, 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. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Neck CT and/or neck MRI, and PET-CT * Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Distant metastasis. * Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast. * Inability to undergo PET-CT. * Stage I and II glottic carcinoma. * Gross total excision of both the primary and nodal disease. * Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met. * Prior invasive malignancy with an expected disease-free interval of less than 3 years. * Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. * Subjects may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. * History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

Interventions: DRUG: ENI using IMRT with or without chemotherapy, RADIATION: INRT, RADIATION: ENI

Conditions: Head and Neck Cancer, Larynx, Lip, Oral Cavity and Pharynx

Sites: UT Southwestern; Parkland Health & Hospital System

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Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial

Description:

1. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Assal Rahimi

Gender: FEMALE

Age: 18 Years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06444269

IRB Number: STU-2024-0561

Show full eligibility criteria

Inclusion Criteria:

* 1. Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis. For cohort 1, it is highly recommended those tumors are at least 1 cm.
• Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age \>/= 18 years old and female 4. Greatest Tumor dimension is 3cm or less based on US. MRI measurements can be included only if performed BEFORE the biopsy 5. Tumor must be unifocal 6. The tumor must be visible on CT scan and/or preferably marked with clip(s) in tumor if not visible. At least one clip should be placed in or around tumor prior to enrollment 7. Patients must undergo an MRI for work up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are present, they need to have a negative biopsy to proceed with treatment.
• Clinically and radiographically node negative on ultrasound of the axilla or MRI on on initial workup prior to microbubble contrast assessment 9. Estrogen receptor positive or Progesterone receptor positive and Her2neu negative 10. Ability to understand and the willingness to sign a written informed consent.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
• If patient has had a prior biopsy clip placed in the lymph node deemed the sentinel lymph node at time of microbubble CEUS, it is up to investigator if additional biopsy and clip placement will be obtained.

Exclusion Criteria:

• 1. Multi-centric disease 2. Prior Radiation to the involved breast 3. Tumor Size \>3cm 4. Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females 5. Prior ipsilateral breast cancer 6. Patients with active lupus or scleroderma 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gadolinium or other agents used in study.
• If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only N0 patients to be treated on this study.

Interventions: RADIATION: Radiomics on MRI, DRUG: microbubble CEUS Contrast Enhanced Ultrasound (CEUS)

Conditions: Breast Cancer, Breast - Female

Sites: UT Southwestern; Parkland Health & Hospital System

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A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Description:

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Farrukh Awan

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06428019

IRB Number: STU-2024-0660

Show full eligibility criteria

Interventions: DRUG: Venetoclax, DRUG: Acalabrutinib, DRUG: Obinutuzumab

Conditions: Chronic Lymphocytic Leukemia, Lymphoid Leukemia

Keywords: Chronic Lymphocytic Leukemia, CLL, Venetoclax, ABT-199, Obinutuzumab, Acalabrutinib

Sites: UT Southwestern

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Bionic Pancreas in CFRD

Description:

This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system.

Contact(s):

Lindsay Allen Lindsay.Allen@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age: 14 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06449677

Show full eligibility criteria

Inclusion
• Age ≥ 14 years old at time of signing informed consent
• Able to provide informed consent (and assent for participants \<18 years old)
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: * Sweat chloride equal to or greater than 60 mmol/liter by quantitative pilocarpine iontophoresis test (QPIT) (when not taking a cystic fibrosis transmembrane conductance regulator (CFTR) modulator) * Two well-characterized mutations in the CFTR gene
• Clinical diagnosis of CFRD, defined as a person with CF and diabetes mellitus, treated with insulin for ≥3 months prior to screening
• Using the same insulin regimen for ≥1 month prior to screening and collection of baseline CGM data, with no plans to change regimen during the study: either multiple daily injections of insulin (MDI), basal-only without bolus insulin, an insulin pump without automation, or an automated insulin delivery (AID) system other than the BP (which is an exclusion)
• Total daily insulin dose must be ≥0.1 units/kg
• Able to speak and read English sufficient to understand the pump user interface and provide written materials for safe operation of the BP • For pediatric participants, this applies to both the participant and caregiver
• For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.
• For participants \>18 years old who live alone, participant has a relative or acquaintance who lives within 30 minutes of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and cannot be reached. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.
• No use of a non-insulin glucose-lowering medication, except metformin, that is not approved for use in T1D within 3 months prior to signing informed consent and willing to not use any such medications during the course of the trial. Note: such drugs cannot be used even if prescribed for weight loss rather than glucose-lowering.
• If not currently using a rapid-acting insulin that is approved for use in the iLet pump, willing and able to switch to an approved insulin when using the BP.
• Participant has commercial glucagon available for treatment of severe hypoglycemia or will obtain it prior to randomization
• Willing to authorize the study team to contact the participant's primary physician to inform them about their participation in this study.
• Enrolled in the Cystic Fibrosis Foundation Patient Registry (participants may enroll in the Registry at the time of enrollment if not already enrolled).
• No plans for trips of more than 14 consecutive days outside the United States during the period of study participation
• Investigator believes that the participant can safely use the iLet and will follow the protocol • The investigator will take into account the participant's HbA1c level (there is no upper limit for eligibility), compliance with current diabetes management, prior acute diabetic complications, cognitive ability, and general medical condition. For this reason, there is no upper limit on HbA1c specified for eligibility. Exclusion
• Current use of the BP or an AID system not FDA approved for T1D
• Known hemoglobinopathy (sickle cell trait is not an exclusion)
• Current participation in another diabetes-related interventional trial
• Established history of allergy or severe reaction to adhesive or tape that must be used in the study
• Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 7 months, or sexually active and can become pregnant but not using contraception
• Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor)
• Have started or stopped a CFTR modulator in the 4 weeks prior to screening. • Modifications of the dosing of a CFTR modulator is acceptable
• Anticipated lung or liver transplant (on transplant list)
• Lung or liver transplant within one year prior to screening. If they have had a transplant more than a year ago, but they: * Have had a rejection episode occur in prior 8 weeks, individual is excluded. * Their doses of corticosteroids and/or calcineurin inhibitors have not been stable for one month prior to enrollment and/or is expected to change significantly over the course of the study, individual is excluded.
• Acute pulmonary exacerbation or hospitalization within the 4 weeks prior to screening or treatment with IV antibiotics in the 4 weeks prior to screening
• History of a complete pancreatectomy
• Currently using enteral tube feedings for nutritional support
• Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following: * Alcohol or drug abuse * Use of prescription drugs that may dull the sensorium, or hinder decision-making during the period of participation in the study such has opioids or short-acting benzodiazepines * Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g., climbing a flight of stairs) despite medical management; or within the last 12 months before screening: a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting * Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV * History of TIA or stroke in the last 12 months * Severe liver disease such as end-stage cirrhosis * Renal failure requiring dialysis or known eGFR \<30 * Untreated or inadequately treated mental illness * History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia or omission of insulin to manipulate weight * History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
• Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.

Interventions: DEVICE: iLet Bionic Pancreas System (BP), DEVICE: Usual Care (UC)

Conditions: Cystic Fibrosis-related Diabetes

Keywords: Cystic fibrosis-related diabetes (CFRD), iLet bionic pancreas, Automated insulin delivery, Continuous glucose monitoring

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Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND) (TRANSCEND)

Description:

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Hila.AbushSegev@UTSouthwestern.edu

Principal Investigator: Kala Bailey

Gender: ALL

Age: 22 Years to 70 Years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06423430

IRB Number: STU-2024-0461

Show full eligibility criteria

Interventions: DEVICE: Sham-stimulation, DEVICE: Active-stimulation

Conditions: Treatment Resistant Depression, Psychiatric Disorders

Keywords: DBS, Major Depressive Disorder, Bilateral Stimulation, Antidepressant Treatment, neurostimulation, ABT-CIP-10494

Sites: UT Southwestern

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A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM). (CEDAR-HCM)

Description:

The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Contact(s):

studyfinder@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age: 12 Years to 17 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06412666

Show full eligibility criteria

Inclusion Criteria:

* Period 1: Treatment Period * Males and females between 12 and \< 18 years of age at screening and at Day 1. * Body weight ≥ 45 kg for the initial cohort and then body weight ≥ 35 kg after at least 10 participants in the initial cohort have undergone dose titration up to Week 4 without observed events of LVEF \< 50% at the starting dose of 5 mg qd. * Core laboratory confirmation of the following oHCM echocardiographic criteria at screening: * Left ventricular (LV) hypertrophy with nondilated LV chamber in the absence of other cardiac disease. * LV end-diastolic wall thickness that meets a threshold of: * Z-score \> 2.5 in the absence of family history OR * Z-score \> 2 in the presence of positive family history or positive genetic test. * LVEF ≥ 60% AND Valsalva LVOT-G ≥ 50 mmHg. * oHCM of sarcomeric origin confirmed by genetic testing or, if unable to confirm by genetic testing, oHCM of sarcomeric origin may be presumed in the absence of history of metabolic disorders, mitochondrial cardiomyopathies, neuromuscular disease, malformation syndromes, infiltrative diseases/inflammation, and endocrine disorders (such as Fabry's disease, Noonan syndrome with left ventricular hypertrophy, and amyloid-cardiomyopathy). * New York Heart Association (NYHA) Class ≥ II at screening. * Adequate acoustic windows for echocardiography. * Participants on beta blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for more than 4 weeks prior to randomization. * Period 2: Open-Label Extension * Completed Period 1. If unable to complete Period 1 due to circumstances not related to compliance or safety, the Medical Monitor may review and determine eligibility. * LVEF ≥ 55% after washout. * Period 3: Long-term Extension • Completed Period 2.

Exclusion Criteria:

* Period 1: Treatment Period Any of the following criteria will exclude potential participants from the trial: * Significant valvular heart disease. * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction. * Mitral regurgitation that is greater than mild in severity and not due to systolic anterior motion of the mitral valve (per judgment of Principal Investigator or designee). * Evidence of fixed left-sided obstruction (eg, subaortic membrane, aortic valve stenosis, or coarctation of the aorta). * History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy at any time during their clinical course. * History of congenital heart disease other than oHCM (may be enrolled if not hemodynamically significant in the judgement of the Principal Investigator and study Medical Monitor). * Has been treated with SRT (surgical myectomy or percutaneous alcohol septal ablation) within the preceding 6 months or has plans for either treatment during the trial period. * History of paroxysmal or persistent atrial fibrillation or atrial flutter. * History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia within 3 months prior to screening. * History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Principal Investigator (or designee) or the Medical Monitor, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. * Current or previous use of drugs known to cause cardiomyopathy (eg, anthracyclines, monoclonal antibodies \[trastuzumab\], alkylating agents \[cyclophosphamide\], and tyrosine kinase inhibitors \[sunitinib and imatinib\]). * Currently participating in another investigational device or drug trial or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. * Implantable cardioverter defibrillator (ICD) implantation within 6 weeks of screening or planned ICD implantation during the trial period. * Has received prior treatment with aficamten or mavacamten. * Currently listed for heart transplantation or anticipated to be listed for heart transplantation in the next 12 months.

Interventions: DRUG: Aficamten, DRUG: Placebo

Conditions: Pediatric, Symptomatic Obstructive Hypertrophic Cardiomyopathy

Keywords: CK-3773274, CK-274, Aficamten, Symptomatic Obstructive Hypertrophic Cardiomyopathy, oHCM, CEDAR, CEDAR-HCM, CY 6023

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Training for Urinary Leakage Improvement After Pregnancy (TULIP)

Description:

This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, AGNES.BURRIS@UTSouthwestern.edu

Principal Investigator: David Rahn

Gender: FEMALE

Age: 18 Years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06411158

IRB Number: STU-2024-0318

Show full eligibility criteria

Interventions: OTHER: Interventionist-guided training, DEVICE: Home pelvic floor exercises guided by the leva® device, OTHER: Education

Conditions: Urinary Incontinence, Delivery Complication

Keywords: Urinary Incontinence, Pelvic Floor Disorders, Physical Therapy, Biofeedback, Anal Incontinence

Sites: UT Southwestern; Parkland Health & Hospital System

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Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer (STAR-EV)

Description:

STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Level 0: EV treatment followed by RT to the bladder Level 1: EV treatment with RT starting on Cycle 2, Day 15 Level 2: EV treatment with RT starting on Cycle 1, Day 15 Following completion of EV+RT neoadjuvant therapy, all subjects will undergo surgery as part of routine care.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Tian Zhang

Gender: ALL

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06394570

IRB Number: STU-2024-0374

Show full eligibility criteria

Inclusion Criteria:

• Urothelial carcinoma of the urinary bladder stage cT2-4a (AJCC 8th edition) N0M0 planned for radical cystectomy. Mixed cell types with variant histologies (including squamous, plasmacytoid, adenocarcinoma, sarcomatoid, micropapillary, nested, and lipid cell variants) are allowed as long as any urothelial histology is present (i.e. -not 100% variant histology). Small cell/neuroendocrine component is excluded.
• Ineligibility for cisplatin-based chemotherapy based on treating physician assessment and any of the following "Galsky criteria": renal insufficiency (Creatinine Clearance \<60ml/min by standard institutional calculation method), \>=grade 2 peripheral neuropathy, \>=grade 2 hearing loss, New York Heart Association (NYHA) class III heart failure; a combination of these; or patient refusal.
• Age \>=18.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
• Adequate organ and marrow function as defined below: •Hematologic: -Absolute neutrophil count (ANC) \>=1500/mm3 * Platelet count \>=100x109/L * Hemoglobin ≥ 9 g/dL •Hepatic: * Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN •Renal: * No end stage renal disease requiring dialysis allowed
• All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months following completion of study neoadjuvant therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 6a. 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).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• No prior systemic therapy (except prior therapy for non-muscle invasive bladder cancer \>12 prior to registration) for bladder cancer or prior pelvic radiotherapy. Prior intra-vesical therapies are allowed, including Bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer. Prior chemotherapy for other cancers is allowed if given \>=1 year prior to study registration.
• Baseline \>= Grade 2 sensory or motor neuropathy
• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to enfortumab vedotin or other agents used in study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Interventions: DRUG: Enfortumab vedotin

Conditions: Bladder Cancer, Urinary Bladder

Sites: UT Southwestern

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FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (AlphaBreak)

Description:

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA radioconjugate (RC). The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Orhan Oz

Gender: MALE

Age: 18 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06402331

IRB Number: STU-2024-0295

Show full eligibility criteria

Key

Inclusion Criteria:

* Phase 2: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Diagnosis of adenocarcinoma of prostate proven by histopathology. * Must have had prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone * Progressive mCRPC at time of study entry. * Must have been previously treated with lutetium-PSMA therapy (lutetium-177 vipivotide tetraxetan or other lutetium-177-PSMA RLT). Treatment must have been completed \>6 weeks prior to the first dose of study drug. * Participants with known BRCA mutations should have received FDA-approved therapies such as PARP inhibitors, per Investigator discretion. * Positive PSMA PET/CT scan * Adequate organ function * For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must use a method of birth control with adequate barrier protection deemed acceptable by the Principal Investigator during the study treatment and for six months after last study drug administration. Key

Exclusion Criteria:

* Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC. * Phase 2: participants who progress prior to administration of the 3rd cycle of prior treatment with 177Lu-PSMA therapy * All prior treatment-related adverse events must have resolved to Grade ≤1 (CTCAE v5.0). Alopecia and stable persistent Grade 2 peripheral neuropathy may be allowed at the discretion of the Investigator. * Participants with known, unresolved, urinary tract obstruction are excluded. * Administration of any systemic cytotoxic or investigational therapy ≤30 days of the first dose of study treatment or five half-lives, whichever is shorter. Completion of large-field external beam radiotherapy ≤four weeks of the first dose of study treatment. * Participants with a history of central nervous system (CNS) metastases are excluded except those who have received therapy * Participants with any liver metastases will be excluded from the Phase 2 segment of the study. * Participants with skeletal metastases presented as a superscan on a ⁹⁹ᵐTc bone scan. * Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma and superficial bladder tumors. Any cancer curatively treated \>two years prior to the first dose of treatment is permitted. * Concurrent serious (as determined by the investigator) medical conditions * Major surgery ≤30 days prior to the first dose of study treatment.

Interventions: DRUG: FPI-2265

Conditions: Metastatic Castration-resistant Prostate Cancer, Prostate

Keywords: mCRPC, 225Ac-PSMA-I&T, Radioligand therapy

Sites: UT Southwestern

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Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Description:

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Heather McArthur

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06393374

IRB Number: STU-2024-0480

Show full eligibility criteria

Inclusion Criteria:

* Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Has no evidence of locoregional or distant relapse, as assessed by the treating physician * Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC * Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery * Has non-pathologic complete response at surgery * Is able to continue on adjuvant pembrolizumab * Randomization must be conducted within 16 weeks from surgical resection * Completed adjuvant radiation therapy (if indicated) and recovered before randomization * Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception * For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia) * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization

Exclusion Criteria:

* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available * Has Grade \>2 peripheral neuropathy * History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC * Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks * Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137) * Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has concurrent active hepatitis B and hepatitis C virus infection * Has history of allogeneic tissue/solid organ transplant

Interventions: BIOLOGICAL: Pembrolizumab, BIOLOGICAL: Sacituzumab tirumotecan, DRUG: Capecitabine

Conditions: Triple-Negative Breast Cancer, Breast - Female

Sites: UT Southwestern; Parkland Health & Hospital System

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Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations (HARMONY)

Description:

This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s). These include pathologic alterations in BRCA 1/2, BRIP1, CHEK2, FANCA, PALB2, RAD51B, and/or RAD54L. A total of 64 people will be enrolled to the study.

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Qian Qin

Gender: MALE

Age: 18 Years to old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06392841

IRB Number: STU-2024-0476

Show full eligibility criteria

Inclusion Criteria:

• Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• ≥ 18 years of age at the time of consent.
• Self-identify as Hispanic/Latino or non-Hispanic black racial/ethnic background.
• ECOG Performance Status of ≤ 2 within 30 days prior to registration.
• Histologically confirmed diagnosis of prostate adenocarcinoma.
• Deleterious HRR alteration(s) per any validated test, next generation sequencing (NGS) mutational analysis (tissue or liquid). These include BRCA 1/2, BRIP1, CHEK2, FANCA, PALB2, RAD51B, and/or RAD54L.
• Radiographic evidence of metastatic disease as per conventional CT or MRI of chest, abdomen pelvis and bone scan, according to RECIST version 1.1 criteria in subjects with measurable disease and PCWG3 criteria for subjects with bone only disease (1, 2). Evidence of metastatic disease detected on Axumin or PSMA PET/CT will need confirmation on conventional CT or MRI/bone scans.
• Hormone sensitive, treatment naïve/minimally treated \[first generation androgen receptor inhibitor (ARI) such as bicalutamide ≤ 45 days, ADT ± abiraterone acetate plus prednisone ≤ 45 days allowed\]. Prior therapy for localized prostate cancer allowed (including but not limited to radiation therapy, prostatectomy, lymph node dissection ± ADT, must have been completed \> 6 months prior to registration).
• Demonstrate adequate organ function as defined below. All screening labs to be obtained within 30 days prior to registration. * Platelets (Plt): ≥ 100 x 10\^9/L (Independent of transfusions for at least 28 days prior to registration) * Absolute Neutrophil Count (ANC): ≥ 1.5 x 10\^9/L (Independent of hematopoietic growth factors for at least 28 days prior to registration) * Hemoglobin (Hgb): ≥ 9 g/dL (Independent of transfusions for at least 28 days prior to registration) * Creatinine: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min * Total bilirubin: ≤ 1.5 × ULN or direct bilirubin ≤ 1 x ULN (For subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤1.5 × ULN, subjects may be eligible.) * Aspartate aminotransferase (AST): ≤ 3 × ULN * Alanine aminotransferase (ALT): ≤ 3 × ULN * Serum potassium: ≥ 3.5 mmol/L
• Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.
• Able to swallow the study medication tablets whole.
• Life expectancy ≥ 12 months.
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

• Prostate cancer variants including predominant neuroendocrine features and/or predominant small cell carcinoma of the prostate are excluded.
• Prior treatment with the following is excluded: second generation ARIs such as apalutamide, enzalutamide, darolutamide, or other investigational ARIs; oral ketoconazole as antineoplastic treatment for prostate cancer (allowed if total time on ketoconazole as prostate cancer-directed therapy is ≤ 10 days and discontinued prior to study treatment initiation); chemotherapy or immunotherapy for prostate cancer.
• Radiotherapy/radiopharmaceuticals within 2 weeks of registration.
• History of severe allergic anaphylactic reactions to niraparib/abiraterone acetate tablets or any of their excipients.
• Current evidence of any medical condition that would make prednisone use contraindicated.
• Long-term use of systemically administered corticosteroids (\> 5mg of prednisone or the equivalent) during the study is not allowed (5mg of prednisone or equivalent daily, given with abiraterone acetate, is allowed). Short-term use of corticosteroid for indication other than in combination with abiraterone acetate (≤ 4 weeks, including taper) and locally administered steroids (eg, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated.
• Subjects who have had major surgery ≤ 28 days prior to registration.
• Symptomatic brain metastases.
• Active or symptomatic viral hepatitis or chronic liver disease; encephalopathy, ascites, or bleeding disorders secondary to hepatic dysfunction.
• Moderate or severe hepatic impairment (Class B and C per Child-Pugh classification system.
• History of adrenal insufficiency not adequately managed.
• History or current diagnosis of MDS/AML.
• Current evidence within 6 months prior to registration of any of the following: * Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, * Clinically significant arterial or venous thromboembolic events (ie. pulmonary embolism), or clinically significant ventricular arrhythmias.
• Presence of sustained uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg). Subjects with a history of hypertension are allowed, provided that blood pressure is controlled to within these limits by an antihypertensive treatment.
• Human immunodeficiency virus positive subjects with 1 or more of the following: * Not receiving highly active antiretroviral therapy or on antiretroviral therapy for less than 4 weeks. * Receiving antiretroviral therapy that may interfere with the study medication * CD4 count \<350 at screening. * An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening. * Human immunodeficiency virus load \>400 copies/mL.
• Active infection requiring systemic therapy. NOTE: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
• Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: * Non-muscle invasive bladder cancer. * Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. * Malignancy that is considered cured with minimal risk of recurrence.
• Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days prior to C1D1.

Interventions: DRUG: Androgen Deprivation Therapy (ADT), DRUG: Niraparib/Abiraterone Acetate DAT, DRUG: Abiraterone Acetate, DRUG: Prednisone, DRUG: Docetaxel

Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, CHEK2 Gene Mutation, FANCA Gene Mutation, PALB2 Gene Mutation, RAD51B Gene Mutation, RAD54L Gene Mutation, Prostate

Sites: UT Southwestern; Parkland Health & Hospital System

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Sequential Multiple Assignment Randomized Trial for Bipolar Depression (SMART-BD)

Description:

This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Afrida.Khurshid@UTSouthwestern.edu

Principal Investigator: Madhukar Trivedi

Gender: ALL

Age: 18 Years to 75 Years old

Phase: PHASE4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06433635

IRB Number: STU20250272

Show full eligibility criteria

Interventions: DRUG: Cariprazine, DRUG: Aripiprazole/Escitalopram combination, DRUG: Quetiapine, DRUG: Lurasidone

Conditions: Bipolar I Disorder, Depression

Keywords: Bipolar, Depression, Adults, Medication

Sites: UT Southwestern

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The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

Description:

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.

Contact(s):

studyfinder@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age: 45 Years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06383390

Show full eligibility criteria

Inclusion Criteria:

* Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower * Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following: * Coronary artery disease * Cerebrovascular disease * Peripheral arterial disease * Chronic kidney disease defined as: * eGFR \<45 millilitres/minute/1.73 meter squared (mL/min/1.73m\^2) and UACR \>30 milligram/gram (mg/g) (0.030 mg/mg) * eGFR \<60 mL/min/1.73 m\^2 and UACR \>100 mg/g (0.100 mg/mg), or * eGFR \<75 mL/min/1.73 m\^2 and UACR \>300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab) * A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

Diabetes related: * Participants have Type 1 Diabetes or any history of diabetic ketoacidosis CV related: * Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization: * Myocardial infarction * Acute coronary syndrome * Stroke, or * Coronary, peripheral, or carotid artery arterial revascularization procedure. * Have acute decompensated heart failure requiring hospitalization. * Have New York Heart Association (NYHA) Classification Class IV heart failure at screening Kidney related: * Participants have an eGFR \<20 mL/min/1.73 m\^2 at screening * Have UACR \>5000 mg/g (5.000 mg/mg) at screening * Have received any form of dialysis ≤ 90 days from the date of randomization * Have either undergone a kidney transplant or have a transplant procedure scheduled Other medical conditions: * Participants have had or plan to have a surgical treatment for obesity, * Have a history of chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2 * Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

Interventions: DRUG: Retatrutide, DRUG: Placebo

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)

Keywords: Cardiovascular Disease, Kidney Disease, Major Adverse Cardiovascular Events (MACE), Renal Outcomes, Cardiovascular Risk Reduction, Kidney Disease Progression, Cardiometabolic Risk Factors, Cardiovascular Outcomes, Kidney Outcomes, Type 2 Diabetes, Heart Disease, Coronary Artery Disease, Cerebrovascular Disease, Peripheral Arterial Disease, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Cardiovascular (CV) Death, Hospitalization or Urgent Visit Due to Heart Failure (HF), Renal Death, End Stage Kidney Disease (ESKD)

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Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (DACAT)

Description:

Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, DEBORAH.GONZALES@UTSouthwestern.edu

Principal Investigator: David Khan

Gender: ALL

Age: 18 Years to 70 Years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06406114

IRB Number: STU-2024-1178

Show full eligibility criteria

Inclusion Criteria:

• Age 18-70 years old.
• Reaction history consistent with a potential immediate hypersensitivity reaction (pruritus, urticaria, erythema, angioedema, bronchospasm, wheezing, shortness of breath, anaphylaxis, or hypotension) to cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime.
• English speaking or non-English speaking with translation services available.

Exclusion Criteria:

• Severe concomitant medical condition (e.g., unstable coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, poorly controlled asthma, chronic renal failure, cirrhosis, or end-stage liver disease.)
• History of Clostridioides difficile infection
• Chronic spontaneous urticaria or systemic mastocytosis
• Incident reaction required cardiopulmonary resuscitation
• Reaction to 2 or more cephalosporin antibiotics
• Active infection or antibiotic treatment within 7 days
• Treatment with systemic antihistamines or corticosteroids within 7 days
• Treatment with omalizumab or dupilumab within 60 days
• Significant immunosuppression
• Treatment with a beta-blocker or ACE inhibitor within 7 days
• Use of investigational drugs within 60 days of participation
• Anaphylaxis in the last 30 days
• Penicillin anaphylaxis within the past year confirmed with positive penicillin skin tests
• Prison or jail inmates, pregnant women, severe cognitive impairment
• Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
• Past or current medical problems or findings from 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.
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol

Interventions: DRUG: Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing, DRUG: Culprit cephalosporin (cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime) double-blind placebo-controlled drug challenge, DRUG: Similar cephalosporin (cefepime, ceftriaxone, cefaclor, cephalexin, cefixime, or cefdinir) antibiotic double-blind placebo-controlled drug challenge, DRUG: Dissimilar cephalosporin (ceftriaxone or cefazolin) antibiotic double-blind placebo-controlled drug challenge, DRUG: Amoxicillin double-blind placebo-controlled drug challenge

Conditions: Drug Allergy, Cephalosporin Allergy, Drug Hypersensitivity, Antibiotic Allergy, Beta Lactam Adverse Reaction, Drug-Induced Anaphylaxis, Cephalosporin Reaction

Keywords: Allergy, Antibiotic, Cephalosporin, Penicillin, Beta-lactam, Drug challenge, Skin testing, Adverse reaction, Anaphylaxis, Perioperative anaphylaxis

Sites: UT Southwestern

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Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder (AMAZE)

Description:

This is an observational study to: * evaluate the on-treatment clinical performance of ravulizumab in relation to the pre-treatment time period (time period prior to exposure), * enhance knowledge regarding conventional MRI outcomes in people with NMOSD treated with ravulizumab, * identify factors suggestive of subclinical disease progression through conventional MRI sequences, * determine if treatment with ravulizumab, impacts longitudinal 3D conformational MRI measures at the dorsal medulla and other regions of the CNS, and * identify biomarkers (e.g., serum neurofilament light chain (sNfL), conventional and novel MRI markers, etc.) related to disease activity.

Contact(s):

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

Principal Investigator: Darin Okuda

Gender: ALL

Age: 18 Years to old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06398158

IRB Number: STU-2023-0744

Show full eligibility criteria

Interventions: DRUG: Ravulizumab

Conditions: Neuromyelitis Optica, Brain and Nervous System

Sites: UT Southwestern

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A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma

Description:

A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma

Contact(s):

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Principal Investigator: Larry Anderson

Gender: ALL

Age: 18 Years to old

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06381141

IRB Number: STU-2024-0479

Show full eligibility criteria

Inclusion Criteria:

• Aged ≥ 18 years at the time of signing the ICF.
• Willing and able to give written informed consent and adhere to protocol requirements.
• Patient has a history of multiple myeloma with relapsed and refractory disease as defined by the protocol.
• Patients must have measurable disease (as determined by the local laboratory) as defined by the protocol.
• Performance status of 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) performance scale.
• Estimated life expectancy of 12 weeks or longer.
• Prior palliative radiotherapy must have been completed at least 14 days prior to dosing on Cycle 1 Day 1.
• Toxicities related to prior study therapy should have resolved to Grade 1 or less according to criteria of NCI CTCAE v5.0, except for alopecia. Patients with chronic but stable Grade 2 toxicities may be allowed to enroll after an agreement between the Investigator and Sponsor.
• Have adequate liver and kidney function and hematological parameters within a normal range as defined by the protocol.

Exclusion Criteria:

• Patient has symptomatic central nervous system involvement of MM.
• Patient has nonsecretory MM, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
• Patient had a prior autologous stem cell transplant ≤ 3 months prior to first dose of study drug on Cycle 1 Day 1.
• Patient had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior first dose of study drug on Cycle 1 Day 1 or is on systemic immunosuppression for graft-versus-host disease.
• Patients with concomitant second malignancies (Except adequately treated non-melanomatous skin cancers, ductal carcinoma in situ, superficial bladder cancer, prostate cancer, Grade 1 stage 1A/1B endometrioid endometrial cancer or cervical cancer in situ) are excluded unless in complete remission three years prior to study entry, and no additional therapy is required or anticipated to be required during study participation.
• Patients with any active autoimmune disease or a history of known or suspected autoimmune disease, or history of a syndrome that requires systemic corticosteroids treatment or immunosuppressive medications, except for patients with vitiligo, resolved childhood asthma/atopy or autoimmune thyroid disorders on stable thyroid hormone supplementation.
• A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
• Treatment with systemic antiviral, antibacterial or antifungal agents for acute infection within ≤ 7 days of first dose of study drug on Cycle 1 Day 1.
• Patient has active peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI-CTCAE v5.0.
• Diagnosed with HIV, Hepatitis B, or Hepatitis C infection.
• Treatment with non-oncology vaccines for the control of infectious diseases (i.e., HPV vaccine) within 28 days of first dose of study drug on Cycle 1 Day 1.
• Active SARS-CoV-2 infection based on positive SARS-CoV-2 test within 4 weeks prior to enrollment or patients with suspected active infection based on clinical features or pending results.
• Has received immunosuppressive medications including but not limited to CellCept, methotrexate, infliximab, anakinra, tocilizumab, cyclosporine, or corticosteroids (≥ 10 mg/day of prednisone or equivalent), within 28 days of first dose of study drug on Cycle 1 Day 1.
• Patient has history of drug-related anaphylactic reactions to any components of CLN-619. History of Grade 4 anaphylactic reaction to any monoclonal antibody therapy.
• Certain treatment with investigational agents and other anti-neoplastic therapy as defined by the protocol
• Female of child-bearing potential (FOCBP) who is pregnant or breast-feeding, plans to become pregnant within 120 days of last study drug administration or declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days after the last dose of study drug administration.
• Male patients who plans to father a child or donate sperm within 120 days or 5 half-lives of CLN-619, whichever comes later, of last study drug administration, or who has a partner who is a FOCBP, and declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days or 5 half-lives of CLN-619, whichever comes later, after the last dose of study drug administration.

Interventions: DRUG: CLN-619

Conditions: Multiple Myeloma

Keywords: Relapsed and Refractory Multiple Myeloma

Sites: UT Southwestern

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Home-based Cardiac Rehabilitation in Heart Failure

Description:

This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization between rural and urban populations, with the goal to assess implementation of cardiac rehabilitation across these two geographic areas. . The study will randomize 332 patients with heart failure (ejection fraction ≥35%) who are not eligible for center-based rehabilitation to either a 12-week mHealth cardiac rehabilitation program or an attention control group, with outcomes measured over 6 months using a composite endpoint of mortality, hospitalizations, and quality of life. We will then assess the implementation of the intervention.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Neil.Keshvani@UTSouthwestern.edu

Principal Investigator: Ambarish Pandey

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06349941

IRB Number: STU-2023-0745

Show full eligibility criteria

Interventions: DEVICE: Movn app, DEVICE: Accelerometer

Conditions: Heart Failure

Keywords: telehealth, heart failure, rural, cardiac rehabilitaion

Sites: UT Southwestern

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A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Description:

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

Contact(s):

Call 214-648-5005
studyfinder@utsouthwestern.edu, Rosemary.Hernandez@UTSouthwestern.edu

Principal Investigator: Sei Chung

Gender: ALL

Age: 18 Years to old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06338995

IRB Number: STU-2024-0309

Show full eligibility criteria

Inclusion Criteria:

* Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP). * Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both. * Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline. * Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:
• Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and
• At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea. * Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Exclusion Criteria:

* Have received a dose of lebrikizumab. * Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period. * Allergen immunotherapy (subcutaneous immunotherapy \[SCIT\]/sublingual immunotherapy \[SLIT\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening) or may require a dose change during study. * Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab. * Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
• B cell-depleting biologics, including rituximab, within 6 months.
• other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
• Systemic immunosuppressants within 4 weeks prior to baseline. * Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening * Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS * Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:
• Nasal septal deviation occluding at least one nostril.
• Antrochoanal polyps.
• Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
• Ongoing rhinitis medicamentosa.
• Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis).
• A nasal cavity tumor (malignant or benign).
• Evidence of fungal rhinosinusitis. * Have anosmia from COVID or any reason other than CRSwNP. * Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening. * Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.

Interventions: DRUG: LY3650150, DRUG: Placebo, DRUG: Standard therapy for INCS

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Sites: UT Southwestern

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Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study (CHESS)

Description:

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

Contact(s):

studyfinder@utsouthwestern.edu

Principal Investigator:

Gender: ALL

Age: 40 Years to 90 Years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06347796

Show full eligibility criteria

Inclusion Criteria:

• Age 40-90 years inclusively.
• Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment and the contralateral side is asymptomatic and \< 5 mm in thickness.
• CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
• Qualifying baseline head CT performed within the 7 days prior to randomization.
• Able to undergo assigned treatment within 72 hours after randomization.
• Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

• Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
• Tentorial or interhemispheric SDH.
• Previous craniotomy for the treatment of CSDH if the craniotomy exceeds 7 cm at the maximal dimension on the baseline CT.
• Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
• Pre CSDH mRS of 5 or higher.
• Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG \> 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for reason other than CSDH.
• Secondary to CSDH, ASR of 0, 1, or 2.
• Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
• Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
• Indication that withdrawal of care will be implemented for the qualifying SDH.
• Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
• On tranexamic acid.
• Platelet count of \<100,000 per microliter refractory to transfusion.
• Coagulopathy that cannot be corrected to an INR of ≤1.5.
• Known contraindications to angiography.
• Known intolerance to occlusion procedures.
• Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection.
• Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
• Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.
• Patient has a known active systemic infection or sepsis.
• Patient is pregnant, planning to become pregnant, or lactating.
• Life expectancy of less than 6 months due to comorbid terminal conditions.
• Concurrent participation in another research protocol for investigation of an experimental therapy.
• Known or suspected to not be able to comply with the study protocol.
• No measurable deficit secondary to the CSDH on the Timed Up and Go \[TUG\], Aphasia Severity Rating \[ASR\], or MRC. At baseline, a measurable deficit on the TUG is defined as: time \>10 seconds. At baseline, a measurable deficit on the ASR is defined as: a score\<4. At baseline, a measurable deficit on the MRC is defined as: a score \< 5 in any muscle group contralateral to the site of the CSDH.

Interventions: PROCEDURE: Conventional Surgery, DEVICE: Middle Meningeal Artery Embolization (MMAE)

Conditions: Chronic Subdural Hematoma

Keywords: chronic subdural hematoma (CSDH), middle meningeal artery embolization (MMAE)

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