Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

Date Added
February 18th, 2026
PRO Number
Pro00148285
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This research study is testing how well a combination of investigational drugs—N-803 and Tislelizumab with Docetaxel—works compared to Docetaxel alone in treating advanced non-small cell lung cancer (NSCLC). The drugs being studied are not yet approved by the FDA. Participants will be randomly assigned to one of two groups (like flipping a coin): the experimental group (receiving the drug combination) or the control group (receiving Docetaxel alone). For every 3 people, 2 will be randomized to the experimental group. You are being asked to join because your cancer has progressed after standard treatment and has become resistant to immune checkpoint inhibitors. Clinic visits will last about 3 to 4 hours and include routine tests and procedures. Treatment will continue until your cancer worsens, you experience severe side effects, choose to stop, or your doctor decides it's best to end treatment. After treatment ends, you'll have a follow-up visit and then be contacted every 3 months for up to 36 months to check on your health, either in person or via telemedicine. N-803 may cause side effects such as fever, high blood pressure, fatigue, itching, diarrhea, nausea, injection site reactions.

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

WATER IV Prostate Cancer: Aquablation versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer

Date Added
February 13th, 2026
PRO Number
Pro00145818
Researcher
Eric Wallen

List of Studies

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

This study is for male subjects that have been diagnosed with prostate cancer. Subjects are expected to remain in the study for a minimum of 12years or longer. There will be a total of 6 subjects locally enrolled. Subjects may experience the following risks: Bladder or prostate capsule perforation, Bladder neck contracture, Bleeding or blood in the urine, Bruising, Cancer progression, Electric shock/burn, Embolism, Incontinence or overactive bladder, and Infection.

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

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

Date Added
February 10th, 2026
PRO Number
Pro00148898
Researcher
Ashley Waring

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is being done to learn more about the study drug known as AZD0780. AZD0780 is investigational meaning it has not yet been approved for commercial uses by the Food and Drug Administration (FDA) but has been approved for use in this study. This study will evaluate the efficacy, safety and tolerability of AZD0780. AZD0780 is taken once daily by mouth. This is a randomized study which means you will be assigned by chance, like flipping a coin, and you will have a 1 in 2 chance of being assigned to the study drug or placebo. Placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor your study doctor or study team will know if you are assigned to study drug or placebo.

Participation in this study will last up to 4.5 years and include up to 15 visits. Study related procedures include medical history collection, physical exams, electrocardiogram (ECG – a test that records the heart's electrical activity), questionnaire and bloodwork. There are risks related to the study drug including increased blood pressure, shortness of breath and vomiting.

Institution
MUSC
Recruitment Contact
Melissa Amitrano
843-876-5009
amitrano@musc.edu

A Phase 1 Dose Escalation Trial Evaluating an Intravenously Administered Recombinant Adeno-associated Virus Serotype rh.74 (AAVrh.74) Vector Containing the Human BCL2-associated Athanogene 3 (BAG3) Gene Coding Sequence (RP-A701, AAVrh.74-BAG3) in Subjects with Dilated Cardiomyopathy Arising from Pathogenic BAG3 Variants (BAG3-DCM)

Date Added
February 10th, 2026
PRO Number
Pro00149195
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Drug Studies, Genetics, Heart
Summary

This study is seeking participants with BAG3-associated dilated cardiomyopathy (DCM). BAG3-DCM is a rare genetic disorder. Dilated cardiomyopathy is a condition that causes the heart to have a harder time pumping blood to the rest of the body which can lead to heart failure. Current treatment for BAG3-DCM is focused on improving heart function and preventing advanced heart failure with medicines, procedures and devices.

This study involves gene therapy. This will be the first time that a BAG3 gene containing study drug will be tested in human volunteers. The purpose of this research is to learn whether the investigational gene therapy RP-A701 is safe and effective for patients with BAG3-DCM. Gene therapy involves the addition of one or more genes to your cells to replace a missing gene or correct malfunctioning genes. Investigational means it is not currently approved by the Food and Drug Administration (FDA). RP-A701 will be given as a one time infusion into a vein in your arm.

Participation in this study will last about 2 years and include at least 18 visits including an inpatient hospitalization stay of at least 5 days. Study related procedures include review of your medical records, study drug infusion, immunosuppressant and antibiotic medications, echocardiogram (ultrasound test of your heart) exercise testing, electrocardiogram (recording of your heart's electrical activity), heart biopsy (collecting a piece of heart tissue), cardiac MRI, questionnaires, heart rhythm monitoring and ICD interrogations, and collection of blood, saliva, urine and stool collection. Study related risks related to gene therapy and those related to study procedures including risks of the heart catheterization, radiation, and biopsy, exercise testing, blood draw risks, genetic testing risks, the risk of loss of confidentiality and unknown risks.

Institution
MUSC
Recruitment Contact
Clara Andrews
843-876-5011
andrewcl@musc.edu

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Date Added
January 27th, 2026
PRO Number
Pro00146193
Researcher
Abirami Sivapiragasam

List of Studies

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

This study is for patients that have been diagnosed with breast cancer. The purpose of this research is to assess the safety and efficacy of sacituzumab tirumotecan (sac-TMT) in people with certain types of breast cancer who will have surgery to remove their breast cancer. This trial will compare two treatment plans that patients will receive before their surgery. One of these treatment plans will involve patients receiving Sac-TMT and pembrolizumab (pembro), followed by chemotherapy and pembro. Patients enrolled in the other treatment plan will receive chemotherapy and pembro. Patients will be given the drug intravenously (a needle in a vein). Patients may experience a decrease in white blood cells, platelets, and red blood cells (anemia). Patients are expected to remain in the study for a minimum of 30 months or longer. There will be a total of 12 patients locally enrolled.

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

A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab versus Placebo, in Combination with Pembrolizumab, Pemetrexed, and Carboplatin, in First-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-01)

Date Added
January 21st, 2026
PRO Number
Pro00147574
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is testing a new medicine called Visugromab (CTL-002) to see if it helps people with a type of lung cancer called metastatic non-squamous non-small cell lung cancer. Everyone in the study will get standard cancer treatment, but some will also get Visugromab while others get a placebo (a look-alike with no active drug), and who gets what is decided randomly—like flipping a coin. The goal is to find out if Visugromab makes the treatment more effective and safe. The study will last up to two years, with Treatment in cycles lasting 3 weeks, about once a month. Researchers will closely monitor participants to see how well the treatment works and how their bodies respond. Serious risks of treatment may include heart problems, low oxygen levels, infections, organ failure, and inflammation in various parts of the body such as the lungs, liver, intestines, pancreas, and thyroid.

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

Magnetic Cell Selection System for CD34+ Cells From HPC-Apheresis Used in Treatment of Acute Myeloid Leukemia

Date Added
January 20th, 2026
PRO Number
Pro00148616
Researcher
Alexander Coltoff

List of Studies

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

This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.

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

A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or Without Cemiplimab (REGN2810) for Participants Previously Treated with Platinum-based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Date Added
January 15th, 2026
PRO Number
Pro00149083
Researcher
Christopher Rangel

List of Studies

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

This study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.

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

A Phase II Study of Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer

Date Added
January 14th, 2026
PRO Number
Pro00149057
Researcher
John Kaczmar

List of Studies


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

This study is for patients diagnosed with unresectable locally recurrent or metastatic head and neck cancer. The purpose of this study is to test if adding an investigational drug called amivantamab to the usual chemotherapy (carboplatin and paclitaxel) is more effective in treating head and neck cancer when compared to being treated with carboplatin and paclitaxel alone. Carboplatin and paclitaxel are FDA approved to treat head and neck cancers; however, adding the study drug, amivantamab, 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, chemotherapy, and regular visits with your doctor including follow-up study visits or phone calls every 3 months. There will be about 50 people taking part in this study, approximately 3 participants will be enrolled at MUSC.

Risks include constipation, nausea, rash, vomiting, swelling of arms and/or legs. 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

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



-- OR --