Ehlers Danlos Syndrome Research Biorepository and Database

Date Added
January 9th, 2026
PRO Number
Pro00147160
Researcher
Russell Norris

List of Studies


Keywords
Allergy, Chronic Fatigue, Genetics, Nervous System, Pain, Rare Diseases, Sleep Disorders, Surgery
Summary

This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.

Institution
MUSC
Recruitment Contact
Tayler Goectau
8437921544
goectau@musc.edu

Expanded Access Program of AMTAGVI that is Out of Specification for Commercial Release

Date Added
January 13th, 2026
PRO Number
Pro00148315
Researcher
Russell Jenkins

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study is an expanded access protocol for AMTAGVI that has not yet been released for commercial use.

Making the AMTAGVI product involves collecting immune cells from your cancer, growing more of them in the laboratory, and giving them back to you to treat your cancer. AMTAGVI is a commercially available treatment approved by the FDA (US Food and Drug Administration) for advanced melanoma. However, sometimes during the manufacturing of AMTAGVI, the final product is Out of Specification (OOS). This means that the test results for your product do not meet the accepted established criteria. The purpose of this study is to allow expanded access use of out of specification (OOS) AMATAGVI.

Expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. While this use involves an investigational product, this is not a research study.

Risks include vitiligo, swelling of the middle layer of the eye (uveitis), shortness of breath, and increased heart rate. There will be approximately 8-10 study visits over a 24-month period. Visit durations will vary. Patients may or may not benefit from receiving OOS AMTAGVI when compared to receiving no treatment at all.

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

A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Date Added
July 23rd, 2026
PRO Number
Pro00151187
Researcher
Russell Jenkins

List of Studies

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

This study is for adults diagnosed with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye.

The main purpose of this research study is to learn if the study drug, brenetafusp (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing (or shrink). Nivolumab and relatlimab are FDA approved, however, the study drug, brenetafusp, is still being investigated and is not approved by the FDA.

Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, drug administration, and regular visits with your doctor including follow-up study visits or phone calls. There will be about 680 people taking part in this study, approximately 5 patients will be enrolled at MUSC.

Risks include cytokine release syndrome, which could include flu-like symptoms such as nausea, vomiting, fever, tiredness, headache, chills, difficulty breathing and/or low blood pressure (symptoms may include dizziness or light headedness). Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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



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