A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy

Date Added
July 26th, 2022
PRO Number
Pro00118909
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have metastatic urothelial cancer (mUC). Metastatic means your cancer has spread outside the area where it started and has spread to distant parts or organs of the body. This study is testing an "investigational" (not yet Food and Drug Administration, FDA, approved drug) study drug called sacituzumab govitecan. Sacituzumab govitecan is given intravenously, through IV. The primary purpose of this study is to evaluate treatment with sacituzumab govitecan alone and in combination with other treatments namely cisplatin, avelumab and pembrolizumab improves tumor shrinkage. They are antibodies made in a laboratory that blocks signals that the cancer sends to quiet your immune system. By blocking that signal your immune system can see the cancer as foreign and fight it. The subject may remain in the study for 18 months. They may receive additional treatment beyond 18 months if they are tolerating and showing benefit form the treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

T-reg function changes: a novel immune regulatory effect underlying benefit of statin use on lethal prostate cancer

Date Added
June 21st, 2022
PRO Number
Pro00120567
Researcher
Michael Marrone

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL-GROUP, PHASE 2B STUDY IN TREATMENT-SEEKING PATIENTS WITH CANNABIS USE DISORDER TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF AEF0117 IN REDUCING CANNABIS USE

Date Added
June 16th, 2022
PRO Number
Pro00119686
Researcher
Kevin Gray

List of Studies


Keywords
Drug Studies, Substance Use
Summary

The purpose of this research is to investigate how a trial drug, AEF0117, influences the effects of cannabis and if it is helpful in the treatment of Cannabis Use Disorder (CUD). This is a 20-week, randomized, double-blind, placebo-controlled, parallel-group outpatient clinical trial that will be conducted at approximately 10 research sites in the US.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (RELATIVITY 098)

Date Added
June 1st, 2022
PRO Number
Pro00116818
Researcher
Daniel Reuben

List of Studies


Keywords
Cancer, Cancer/Other, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with stage III-IV Melanoma after a complete resection (no evidence of disease). The investigational drug in this study is relatlimab in combination with nivolumab. Investigational means the drug is not approved by the United States Food and Drug Administration (US FDA). Participants will be assigned to receive relatlimab with nivolumab in a fixed dose combination (FDC, both drugs in a single vial) or nivolumab alone, administered by intravenous (IV) infusion, meaning the drug is a solution given through a vein. The infusion is planned to take 30 minutes. Neither the participants or study doctor will know what is being administered.

This study is designed to explore if treating stage III-IV resectable melanoma patients with this combination, after they have surgery to remove all tumors, will reduce the probability of having progressive disease when compared to nivolumab alone, as well as to assess the possible side effects that this combination therapy might have. Participants can expect to be on this study for a minimum of 6 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Varenicline for treatment of e-cigarette dependence

Date Added
May 17th, 2022
PRO Number
Pro00120081
Researcher
Benjamin Toll

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This is a smoking cessation study which is examining varenicline for use in reducing or quitting e-cigarettes. Half of the participants will receive a placebo pill and half will receive varenicline. All participants will be asked to complete weekly assessments and receive compensation for doing so.

Institution
MUSC
Recruitment Contact
Madeline Foster
8437371516
fostemad@musc.edu

A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease

Date Added
May 11th, 2022
PRO Number
Pro00117678
Researcher
Roberto Pisoni

List of Studies


Keywords
Drug Studies, Genetics, Kidney, Minorities, Rare Diseases
Summary

This randomized, double-blind, placebo-controlled Phase 2/3 adaptive study will first evaluate two doses of VX-147 in subjects with APOL1-mediated proteinuric kidney disease for 12 weeks to select a dose for Phase 3 and subsequently evaluate the efficacy and safety of the single, selected dose in the Phase 3 portion of the study.
The study comprises three periods: screening, treatment, and follow-up. The initial treatment period for Phase 2 is 12 weeks. Subjects enrolled for Phase 2 and Phase 3 who receive the non-selected dose will switch to the Phase 3 dose in a blinded manner after the Phase 3 dose is determined. The study will complete when 187 composite clinical outcome events are accrued among subjects in Phase 2 and Phase 3 who received placebo or the Phase 3 dose and when all enrolled subjects have at least 2 years of eGFR data.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Date Added
May 11th, 2022
PRO Number
Pro00117937
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for participants that have colorectal cancer that has been treated before, spread to other parts of the body and they test positive for a protein called PD-L1. PD-L1 is a protein that helps keep T cells from killing other cells, including cancer cells. This study drug (MK-4280A) is used to block this protein so the "brakes" on the immune system are released and the ability of T cells to kill cancer cells is increased. MK-4280A is a mixture of 2 drugs: MK-4280 (favezelimab) and MK-3475 (pembrolizumab also called pembro). MK-4280A has not been approved by the United States Food and Drug Administration (FDA). This purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) and to compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). Participants will be randomized to one of two groups. Group 1 will get MK-4280A and Group 2 will get a standard treatment. This study has 3 phases: Screeing (about 1 month), Treatment (depends on which drug the participant gets, how well their cancer is controlled, and how they are feeling) and Follow-up (1 visit 30 days after the last dose of study drug, then every 9 weeks, then the study team will contact you every 12 weeks). Participants may experience certain side effects and discomforts from taking the study drug. Because the study drug is experimental, all the side effects may not be known.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder

Date Added
May 3rd, 2022
PRO Number
Pro00119770
Researcher
Lindsay Squeglia

List of Studies