Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients with Cardiomyopathy or at an Elevated Risk of Cardiotoxicity (NeoCARD): A Response Adapted Single-arm Phase 2 Trial

Date Added
June 17th, 2025
PRO Number
Pro00144305
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer/Breast
Summary

This study is for adult patients with Triple Negative Breast Cancer (TNBC) who are at high risk for cardiotoxicity. The purpose of this study is to evaluate a non-anthracycline-based chemotherapy and immunotherapy regimen to determine if this approach reduces heart-related side effects. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 6 months with follow up over 2 years.

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

Can MEP conditioning improve corticospinal recruitment of motoneurons in chronic cervical SCI?

Date Added
July 1st, 2025
PRO Number
Pro00145581
Researcher
Aiko Thompson

List of Studies


Keywords
Movement Disorders, Rehabilitation Studies, Spinal Cord
Summary

The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections.Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, we use a transcranial magnetic stimulator. We hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.

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

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Date Added
July 3rd, 2025
PRO Number
Pro00145386
Researcher
Theodore Gourdin

List of Studies


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

This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.

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

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living with Metastatic Lung Cancer

Date Added
July 8th, 2025
PRO Number
Pro00144605
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer/Lung
Summary

LiveWell is a telehealth-delivered coping skills training program for people living with advanced lung cancer. LiveWell teaches skills from dialectical behavioral therapy, a type of evidence-based psychotherapy, that have been specifically adapted for people living with advanced lung cancer. The skills (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) are designed to help you live as well as possible, with cancer. We are interested in seeing whether the program can help you to balance your emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with lung cancer.
 
If you participate in this study, you will be randomly assigned to one of two groups: the LiveWell group, or usual care. LiveWell involves meeting with a skills trainer once per week for eight weeks via telemedicine, in addition to receiving your usual cancer care. Meetings last 45-60 minutes and are scheduled at a time that works best for you. You will not know whether you will be in the LiveWell group or the usual care group before enrolling in the study, but you will know which group you are in after enrolling. Participants in both groups will complete questionnaires three times: at baseline, 8 weeks later, and 3 months after that. For most people, your participation will last approximately 5 months.  You will be compensated for completing study questionnaires.
 

Institution
MUSC
Recruitment Contact
Kelly Hyland
843-876-8861
hylandk@musc.edu

A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (Prevail Global)

Date Added
July 8th, 2025
PRO Number
Pro00144658
Researcher
Anbukarasi Maran

List of Studies


Keywords
Heart
Summary

This study is evaluating the clinical safety and efficacy of Prevail Drug-Coated Balloon (DCB) in the treatment of in-stent restenosis (ISR) which is the narrowing of heart arteries (blood vessels) previously treated with stents (mesh like medical device that helps keep arteries open) and in new narrowing of arteries in small vessels. The DCB is a small balloon that has medication on it. The medication is designed to reduce the re-occurrence of narrowing in blood vessels. All participants who have a previous stent will be chosen at random to be treated with either the Prevail DCB or the Agent DCB. You will have a 50:50 chance of being assigned to either DCB. The Prevail DCB is considered investigational meaning it has not yet been approved by the Food and Drug Administration (FDA). The Agent DCB is FDA approved. If you are being treated due to a new lesion in a small blood vessel, you will be treated with the Prevail DCB. Study related procedures include the following: electrocardiograph (known as an ECG, which is a test that shows your heart's electrical activity), blood draws, physical examinations, a review of chest pain, and medication history. Participation in this study will take about 5 years and include about 9 visits. Risks include risks related to the DCBs including allergic reaction, GI symptoms or changes to blood counts.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu



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