A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Health Infants.

Date Added
July 31st, 2026
PRO Number
Pro00149890
Researcher
Stephen Stripling

List of Studies

Keywords
Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

A germ called Streptococcus pneumoniae (also known as S pneumoniae) is a leading cause of serious diseases including infection of the lungs (pneumonia), infection of the brain lining (meningitis), infection of the blood (bacteremia) and infection of the ears (otitis). There are more than 90 different types of S pneumoniae, some of which cause more serious infections than others. 20-valent (meaning the vaccine protects against 20 different types of S. pneumoniae) pneumococcal conjugate vaccine (Prevnar 20®; 20vPnC) was approved in 2021 first in adults then in children in the United States in 2023, to prevent pneumococcal disease.

The study vaccine, 25-valent pneumococcal conjugate vaccine (25vPnC, PG4 vaccine, pneumococcal fourth-generation vaccine) contains the same components found in 20vPnC, one of which has been changed, but with 5 additional components to help expand protection against 25 types of S pneumoniae. The study vaccine is not approved by the United States Food and Drug Administration (FDA) or elsewhere around the world.

This study will look at how a new pneumococcal vaccine will work in healthy infants while expanding protection against pneumococcal disease due to the germ called S pneumoniae; and, how the new study pneumococcal vaccine will work together with recommended childhood shots.

This study will last for about 16 to 19 months and will have at least 6 visits and 1 telephone contact, about 6 months after your child's last study vaccination.

Institution
MUSC
Recruitment Contact
Jasmine Dewitt
(843) 305-5798
dewitjas@musc.edu

Women's Aneurysm Research: Repair Immediately or Routine Surveillance: WARRIORS Trial- USA

Date Added
July 23rd, 2026
PRO Number
Pro00151293
Researcher
Jean Ruddy

List of Studies


Keywords
Surgery
Summary

This study is trying to find out whether early repair of small Abdominal Aortic Aneurysms (AAAs) in women improves health outcomes compared to routine monitoring. An AAA occurs when a section of the aorta in the abdomen weakens and bulges outward, resembling a balloon. This condition is serious because if the aneurysm ruptures, it can cause severe internal bleeding and can be fatal. This question is important because women with small AAAs may have a higher risk of rupture than men, and doctors are not yet sure whether early repair is better than standard monitoring. Surgical repair is the elective standard of care for aneurysms above 5.5cm in size. In our study we are evaluating if earlier repair (between 4.0- 5.4 cm) might be beneficial to women with abdominal aneurysms, but it is important to note that surgical repair involves risks and could lead to other complications, including death. These risks are discussed later in this form. There is also the possibility that you may need additional procedures, including open surgery.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer

Date Added
July 23rd, 2026
PRO Number
Pro00151284
Researcher
Anca Dumitriu

List of Studies


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

This study is recruiting patients receiving cancer treatment that includes a type of drug called an "alkylating agent", which may cause side effects such as damage to the ovaries (female reproductive organs). The goal of the study is to determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age <40 years (exclusive of breast cancer). The triptorelin used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. Participants will receive the medications through an intramuscular (IM) injection in their arm. Study participation is expected to last up to three years.

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

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (ELASCOPE)

Date Added
July 23rd, 2026
PRO Number
Pro00150319
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

To evaluate if daily oral administration of elafibranor 120 mg improves the time of event free survival compared to placebo in adults with Primary Sclerosing Cholangitis (PSC).

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu

Expanded Access Program To Treat Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma with Daraxonrasib

Date Added
July 22nd, 2026
PRO Number
Pro00151749
Researcher
Albert Lockhart

List of Studies

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

This study is being offered for patients with metastatic pancreatic adenocarcinoma who have tried available approved treatments and do not have satisfactory treatment options or are unable to participate in a clinical trial. The purpose of this Expanded Access Program (EAP) is to provide access to daraxonrasib, an investigational drug that has not yet been approved by the FDA.

Daraxonrasib is an oral tablet. Clinic visit are every 28 days to receive a new supply of daraxonrasib. Participation is expected to last until whichever of the following occurs first - 1: you are no longer benefiting from daraxonrasib; 2: daraxonrasib becomes commercially available (FDA approved); 3: Revolution Medicines, the Sponsor of the EAP, the IRB, or the FDA decides to stop the EAP.

Risks include skin rash, diarrhea, nausea and vomiting, mouth sores, and swelling. This EAP is not a research study. Its main goal is to provide access to daraxonrasib to patients who may benefit based on what information is known about the drug so far. There is no guarantee that your cancer will get better as a result of receiving daraxonrasib. It is possible that you will show no improvement or that your cancer could get worse.

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

A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age with heart failure (HF) and left ventricular systolic dysfunction (LVSD)

Date Added
July 22nd, 2026
PRO Number
Pro00148694
Researcher
Katerina Boucek

List of Studies

Keywords
Heart, Pediatrics
Summary

This is a 3 month study for pediatric patients between the ages of 6 months and 18 years that have a current diagnosis of heart failure. This study will compare the use of the medication finerenone to placebo. During the study, participants will continue to receive their standard of care therapy according to pediatric heart failure guidelines. At the end of the 3 month study period, participants will have the option to enroll in a 9 month open label extension.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8317
wakefies@musc.edu

A Phase I, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AT03-65 in Adults with Advanced Solid Tumors

Date Added
July 22nd, 2026
PRO Number
Pro00147261
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called At0365-P1-01. "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 how safe the drug is, how well participants can handle the drug, how it moves through the body, how it affects the body, and if the drug helps treat the cancer of AT03-65. AT03-65 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. The estimated study duration is approximately 30-35 months for subjects screening, treatment and follow-up.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Malabsorption as a Cause of Iron Deficiency Anemia

Date Added
July 21st, 2026
PRO Number
Pro00149213
Researcher
Karim Besir

List of Studies

Keywords
Blood Disorders, Nutrition
Summary

Iron deficiency is the most common nutritional deficiency worldwide and is a leading cause of anemia, which can result in symptoms such as fatigue, weakness, shortness of breath, and reduced quality of life. This study aims to better understand why some people develop iron deficiency by examining how the body absorbs iron and how this may relate to diet and proteins involved in iron absorption. Participants will complete questionnaires, provide blood, urine, and stool samples, undergo an oral iron absorption test, and complete a short food diary. If an upper endoscopy is already being performed as part of routine medical care, one additional biopsy sample will be collected during the procedure for research purposes. The information gathered may help improve the diagnosis and evaluation of iron deficiency anemia in the future. Participation involves two study visits over approximately one month. There is no direct medical benefit to participants, but the knowledge gained may benefit future patients with iron deficiency anemia.

Institution
MUSC
Recruitment Contact
Karim Besir
(843) 792-0650
besir@musc.edu

Medical Management with Endovascular Thrombectomy versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well – SELECT LATE trial

Date Added
July 21st, 2026
PRO Number
Pro00146846
Researcher
Sami Al Kasab

List of Studies


Keywords
Stroke
Summary

Select Late will be looking at treatment outcomes in patients presenting with severe blood clot blocking a blood vessel in your brain (ischemic stroke) specifically in one of the large arteries in the brain effecting the front of the brain presenting between 24 and 72 hours after stroke start. The study will be looking at patient outcomes when treated with the standard of care medical management compared to medical management plus endovascular thrombectomy (a surgical procedure to remove a blood clot).

Institution
MUSC
Recruitment Contact
Emily Infinger
8437926210
infingem@musc.edu



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