The ASCEND Trial: A Multicenter, Double Blinded Vehicle Controlled Study of TMB-001, a Proprietary Isotretinoin Ointment, in the Treatment of RXLI (X-linked) or ARCI (Lamellar) Ichthyosis; Preceded by a Voluntary Maximal Use Study; Both Studies in Subjects 6 Years of Age and Above

Date Added
August 10th, 2022
PRO Number
Pro00120937
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Drug Studies, Pediatrics, Skin
Summary

This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects > or = to 6 years of age with lamellar ichthyosis, and aims to assess the bodily absorption of the cream across application frequencies. Subjects with ARCI/RXLI will be randomized 2:1, to either receive the TMB-001 0.05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. Prior to the Phase III trial, subjects will have the option to participate in a 14 day treatment period with TMB-001 0.05% - twice daily - followed by continued treatment with TMB-001 0.05% twice daily for 10 weeks.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)

Date Added
August 8th, 2022
PRO Number
Pro00121904
Researcher
Marc-Andre Cornier

List of Studies

Keywords
Cholesterol, Drug Studies, Heart
Summary

If you are an adult over 40 years of age with atherosclerosis cardiovascular disease (heart attack or ischemic stroke or narrowing of arteries in legs due to plaque) and a LDL cholesterol greater than 70 mg/dL, you may be eligible to take part in a clinical research study. The purpose of this study is to evaluate the benefit of inclisiran on major cardiovascular events while taking either atorvastatin or rosuvastatin cholesterol lowering medications. Study participants will be randomly assigned to take either inclisiran or placebo (inactive medication). Study visits during the treatment period will occur every three months twice and then every six months for up to six years. If eligible, study medication and study visits will be provided free of charge. Compensation is available.

Institution
MUSC
Recruitment Contact
Lori Spillers
843-876-0977
spillerl@musc.edu

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

A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer

Date Added
July 26th, 2022
PRO Number
Pro00121308
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

An experimental drug called HCW9218 is being tested in this study. HCW9218 is not approved by the Food and Drug Administration (FDA) or any other health authority for the treatment of cancer or any other disease. Since HCW9218 is experimental, it is only available to people taking part in this study. This study is for participants diagnosed with advanced pancreatic and the disease has spread or cannot be surgically corrected. This is a Phase 1b/2 study, meaning that it is a first in human research study and there is no data on HCW9218 in humans. This study tests different doses of HCW9218 to see which dose is safer in people, how well the treatment is tolerated and whether it has effects on the disease. The study doctor will tell participants which part of this study that they will take part in, the dose escalation phase or dose expansion phase. The dose escalation phase the part of a study that determines the best dose of a new drug or treatment. In a dose-escalation study, the dose of the test drug is increased a little at a time in different groups of people until the highest dose that does not cause harmful side effects is found. In the dose-expansion part of a study allows more participants to receive the study drug to further test the potential side effects of the drug. HCW9218 is given as an injection under the skin (subcutaneous injection). If participants continue in this study, he/she will begin receiving HCW9218 treatment every 28 days. HCW9218 is given as an injection under the skin (subcutaneous injection). For each day participants receive HCW9218, participants will be treated as an outpatient in a treatment center. Participants will be asked to stay in the treatment center for up to 6 hours after the first dose, 3 hours after the second dose, and 30 minutes after subsequent doses, so that the study team can carefully monitor the body's functions and closely watch for potential side effects of the study drug. This study will last about 4 years. Participants will be treated with HCW9218 until disease progression or until they can no longer tolerate the study drug. Participants could be in this study for up to 3 years. There may be risks associated with being treated with HCW9218. Some of the most common side effects that the study doctors know about based on drugs that are similar to HCW9218 are: injection site irritation/ reaction, fatigue/ tiredness, and flu-like symptoms.

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

A Phase 2 Non-Randomized, Open-label, Multi-Cohort, Multi-Center Study Assessing the Clinical Benefit Of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Head and Neck Squamous Cell Carcinoma (HNSCC) (Pegasus Head and Neck 204)

Date Added
June 28th, 2022
PRO Number
Pro00118783
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is SAR444245 (THOR-707). Investigational means the drug is not approved by the Food and Drug Administration (FDA).

The main purpose of this research study is to determine the antitumor activity of SAR444245 in combination with other approved anticancer therapies.

Participants will have blood draws, CT and/or MRI scans, and receive study drug in a vein (IV). There are risks to the study drug including fever, influenza-like illness, vomiting, nausea, and chills. It is possible that participant's symptoms will improve, but that cannot be guaranteed.

Screening will take up to 28 days. If participants receive treatment for the maximum amount of cycles, they will receive treatment for about 2 years. The end of treatment visit will be about a month after the last treatment is received. Then, participants will have in clinic observational visits every 3 months until disease progression, a new cancer therapy is started or 9 months from the date of first infusion of the last participant. Then, follow up visits by phone every 3 months for about 3 years. Total participation will last about 6 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@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
Marian Chelsea Evangelista
8435097589
evangema@email.sc.edu

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Date Added
May 17th, 2022
PRO Number
Pro00117916
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Exercise, Pain, Physical Therapy
Summary

The purpose of this research study is to study four treatments for chronic low-back pain to learn whether or not certain treatments work better for people with certain characteristics.The study's main goal is to find a way to match treatments to low-back pain patients based on their characteristics and how they responded to treatments they have used before.

This study is a multi-site, sequential, multiple assignment randomized trial (SMART) designed to meet the primary objective of estimating an algorithm for optimally assigning evidence-based interventions for chronic low-back pain. The trial is based on an individual patient's phenotypic markers and response to treatment. Interventions being evaluated in this trial are: (1) acceptance and commitment therapy (ACT), (2) duloxetine, (3) enhanced self-care (ESC), and (4) evidence-based exercise and manual therapy (EBEM).

Institution
MUSC
Recruitment Contact
Haley Schiek
843-764-7309
schiek@musc.edu



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