Expanded Access use of Recombinant Bacillus Calmette-Guerin in Nonmuscle Invasive Bladder Cancer

Date Added
July 14th, 2026
PRO Number
Pro00151312
Researcher
Matvey Tsivian

List of Studies

Keywords
Cancer
Summary

This is a treatment plan to provide recombinant Bacillus Calmette-Guérin (rBCG) to patients with bladder cancer who are eligible to receive TICE® BCG and may benefit from its use. The treatment plan will end if the product is approved for use in the United States or if a Food and Drug Administration (FDA) clinical trial proves rBCG treatment to be ineffective. The drug is not currently FDA approved for bladder cancer.

Subjects will receive rBCG. They will have tests, exams and procedures that are part of standard of care (SoC) and for treatment plan purposes. Participants will receive treatment based on TICEBCG protocol at their local institutions.

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

Prospective RandomizEd Evaluation and Management of Premature Therosclerosis

Date Added
July 10th, 2026
PRO Number
Pro00151795
Researcher
Sheldon Litwin

List of Studies


Keywords
Cholesterol, Heart
Summary

The PRE-EMPT study is designed to identify people who may have early signs of heart disease even though they are considered to be at low risk for heart problems. Participants will undergo specialized heart scans to look for plaque buildup in the arteries that supply blood to the heart. Individuals found to have early plaque may be invited to participate in a treatment phase of the study. In this phase, participants will receive either study medications (rosuvastatin and/or colchicine) or placebo tablets and will also receive support for healthy lifestyle behaviors through a digital health platform. Patients will be randomized to one for four treatment groups. Researchers will follow participants for approximately two years to determine whether these treatments and lifestyle interventions can slow or reduce plaque buildup in the heart arteries. Information gained from this study may help improve strategies for detecting and treating early heart disease in the future.

Institution
MUSC
Recruitment Contact
Melissa Amitrano
8438765009
amitrano@musc.edu

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa

Date Added
July 10th, 2026
PRO Number
Pro00150747
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study will compare the efficacy and safety of SD-101-6.0 cream with SD-101-0.0 (placebo) in approximately 80 patients with Epidermolysis Bullosa (EB), including Simplex, Recessive Dystrophic, and JEB-nH subtypes. Patients will apply SD-101-6.0 or placebo topically once daily to the entire body for 60 days. Each patient will have one target wound that is 21 days or older and 10–50 cm² in size selected at baseline. The primary goal is to determine how many patients in each treatment group achieve complete closure of the target wound (skin re-epithelialization without drainage) by Month 1.

Patients will return for follow-up visits around Days 14, 30, and 60 to assess wound healing using the ARANZ SilhouetteStar™ device, with the target wound measured at each visit until it is documented as closed. Secondary assessments include changes in total wound burden based on body surface area (BSA), itching, and incidence of skin infections across the entire body. Itching will be evaluated at multiple time points but will not be recorded as an adverse event. Patients who complete this trial may be eligible to enroll in an open-label extension study (SD-008) to receive active treatment. Safety will be monitored through adverse event reporting, tolerability assessments, and physical examinations, with urine pregnancy testing performed at the investigator's discretion.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Date Added
July 10th, 2026
PRO Number
Pro00149096
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study is testing and investigational drug called INCB123667. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the efficacy and safety of INCB123667 in terms of objective response rate (ORR) as assessed by an independent review committee (IRC). The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months.

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

20190341: A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Date Added
July 8th, 2026
PRO Number
Pro00150758
Researcher
Wael Ghalayini

List of Studies

Keywords
Cancer/Lung
Summary

This study is being conducted to determine how well participants with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC), that has certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C) respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of your cancer getting worse and improves your survival (i.e. increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. In this study, participants will be screened and if they meet criteria will be enrolled into the main study and assigned, by chance, into one of 2 groups. You will have an equal chance of taking sotorasib platinum doublet combination chemotherapy or pembrolizumab platinum doublet combination chemotherapy. It is hoped that the information gained from the study will help refine future chemotherapy programs.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Freida Davidson
843-674-5172
cormackf@musc.edu

A Micro-Randomized Trial to Optimize a Just-in-Time Adaptive Intervention for Alcohol Craving and Suicide Ideation

Date Added
July 7th, 2026
PRO Number
Pro00151349
Researcher
Margaret Baer

List of Studies

Keywords
Alcohol, Mental Health, Psychiatry, Stage I, Substance Use, Suicide
Summary

Up to 40% of people who want to reduce their drinking have thought about suicide. However, currently there are no treatments that create a plan to manage cravings for alcohol and to manage suicide ideation. This study consists of three studies: Study 1 aims to conduct interviews with adults with lifetime alcohol misuse and thoughts of suicide and with providers who have worked with patients with alcohol misuse. The interviews obtain feedback on a newly developed brief (single appointment) treatment for alcohol craving and thoughts of suicide. Study 2 aims to pilot test the single-appointment treatment and 1 week of text messages with adults with recent alcohol misuse and recent thoughts of suicide. Adults will provide feedback in a brief interview. Study 3 aims to test the single-appointment treatment and 4 weeks of text messages with adults with recent alcohol misuse and recent thoughts of suicide. Specifically, different types of text messages will be tested.

Institution
MUSC
Recruitment Contact
Margaret Baer
567-218-3067
baerm@musc.edu

PHASE III TRIAL OF RADIOTHERAPY FOLLOWED BY ADJUVANT TEMOZOLOMIDE IN COMBINATION WITH THE IDH INHIBITOR VORASIDENIB VS. PLACEBO IN IDH-MUTATED NEWLY-DIAGNOSED GRADE 3 ASTROCYTOMAS

Date Added
July 7th, 2026
PRO Number
Pro00151019
Researcher
Sean Pennetti

List of Studies

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

This study is to compare the usual treatment (radiation plus temozolomide alone) to using the study treatment (usual treatment plus the study drug, vorasidenib). The addition of the study drug, vorasidenib, to the usual treatment could shrink or stabilize your cancer. The study drug is FDA (Food and Drug Administration approved. The study drug will be given orally. The study will randomize (the computer will pick the group that the participant will be enrolled in) participant to Group 1 or Group 2. Participants can expect to be on the trial for 10 years or more. There will 4 participants enrolled locally.

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

Acute characterization of neurophysiological, functional, and quality of life measurements in people with and without neurological injury

Date Added
July 7th, 2026
PRO Number
Pro00148164
Researcher
Aiko Thompson

List of Studies


Keywords
Nerve, Non-interventional, Spinal Cord
Summary

The purpose of this research study is to learn how the nervous system functions in individuals with and without spinal cord injury, and examine how this relates to function. As part of this study, procedures may include nerve stimulation, brain stimulation, imaging (MRI), walking assessments, measures of brain activity, sensation testing, measures of arm or leg function, and self-report measures regarding daily activities and quality of life. The duration of participation depends on the number of procedures to which an individual is consented.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

Pilot Randomized Trial Evaluating Resistance Exercise Training and Creatine Supplementation in Individuals Treated for Head and Neck Cancer

Date Added
July 7th, 2026
PRO Number
Pro00148118
Researcher
Chris Gregory

List of Studies


Keywords
Cancer, Exercise, Rehabilitation Studies
Summary

The study will examine the effects of a 10-week resistance training program, with or without creatine monohydrate supplementation, on changes in body composition, physical function, cancer-related fatigue, quality of life, and symptom burden in head and neck cancer (HNC) survivors. All participants will undergo screening that includes completion of questionnaires, exercise testing and physical function assessments before and after the treatment period as well as at a 10-week follow up evaluation. We hypothesize that group that completes resistance training with creatine monohydrate supplementation will achieve greater improvements in body composition, physical function, cancer-related fatigue, quality of life, and symptom burden when compared to the group that completes resistance training alone.

Institution
MUSC
Recruitment Contact
Brian Cence
(843)792-2668
cence@musc.edu

Automated Speech and Language Assessment to Improve Diagnosis of Neurodegenerative Disorders (SLANG)

Date Added
July 2nd, 2026
PRO Number
Pro00150880
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Nervous System, Speech Disorders
Summary

Researchers at the Medical University of South Carolina are studying speech and language in people with Parkinson's disease (PD), progressive supranuclear palsy (PSP), and multiple system atrophy (MSA), and in healthy adult volunteers. These conditions can change how a person speaks and uses language, and the changes may differ from one condition to another. The study uses a tablet-based set of short speech and language tasks, called SLANG, together with computer software that measures features of the recorded speech, such as pitch, timing, and word choice. Participants also complete standard speech, language, and thinking tests and a brief exam by a neurologist, which researchers compare against the tablet measurements. The purpose of this study is to gather early research data: to build a database of these measurements across the groups, to check whether the tablet captures them reliably, and to explore whether they differ between conditions. SLANG is not used to diagnose participants or to guide their medical care in this study. The long-term goal of this research is to develop a tool that could someday help clinicians recognize and tell these conditions apart earlier, but testing such a tool for diagnosis is beyond the scope of the current study.

Institution
MUSC
Recruitment Contact
Department of Neurology
843-792-0000
waltonc@musc.edu



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