PHASE II STUDY EVALUATING NALIRIFOX VS. MODIFIED GEMCITABINE, NAB-PACLITAXEL, AND CISPLATIN IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC PANCREATIC ADENOCARCINOMA

Date Added
August 19th, 2025
PRO Number
Pro00145838
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Drug Studies, Pancreas
Summary

This study is for patients that have been diagnosed with previously untreated, locally advanced, and metastatic pancreatic ductal adenocarcinoma PDAC. This study is testing two treatment regimens: NALIRIFOX (5-fluorouracil, liposomal irinotecan, oxaliplatin, and leucovorin) vs mGAP (gemcitabine, nab-paclitaxel, and cisplatin).
The primary purpose of this study is to see which of the two regimens is more effective in PDAC. Participants will continue on study medications if seeing clinical benefit, and can expect to be on the study for a maximum of 6 months.

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

Utilizing sFLT-1/PLGF Ratios to Differentiate and Predict Deterioration in Growth-Restricted Fetuses

Date Added
August 15th, 2025
PRO Number
Pro00144214
Researcher
Amartha Gore

List of Studies

Keywords
Obstetrics and Gynecology
Summary

This a blood draw study. Blood samples will be collected every 4 weeks on women diagnosed with fetal growth restriction. We hope it will help to determine other ways to evaluate patients with fetal growth restriction and thus improve outcomes.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

SHORT TERM INTENSIFIED PEMBROLIZUMAB (KEYTRUDA) AND TIVOZANIB FOR HIGH-RISK RENAL CELL CARCINOMA - STRIKE

Date Added
August 12th, 2025
PRO Number
Pro00146260
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is patients that have been diagnosed with high-risk renal cell carcinoma. This study will compare disease free survival (DFS) in patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. Participants can expect to remain in the study for 10years. There will be a total of 14 patient enrolled locally.

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

Study of the Prevalence of Endogenous Hypercortisolism in Patients with Resistant Hypertension (MOMENTUM)

Date Added
August 12th, 2025
PRO Number
Pro00145257
Researcher
Jan Basile

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is looking for individuals who have resistant hypertension. This is a non-interventional research study and it does not involve a new drug or treatment. The goal of this study is to find out how many people with resistant hypertension, a type of high blood pressure that is hard to control, also have high levels of a hormone called cortisol. High cortisol levels, a condition called hypercortisolism, may make it more difficult to manage blood pressure. If you join the study, you will attend two to three clinic visits. During the first visit, you will go to the clinic for a short checkup. You will have vitals and your medical history reviewed. You will also have a blood draw and be given a pill called dexamethasone which will help us assess your cortisol levels. At your second visit you will fast and have a your blood collected to review your cortisol levels. If necessary, you will be invited for a third visit where you will get a CT scan. The risks associated with the study include bruising, dizziness, or, in rare cases, infection from blood draws, allergic reactions from taking the dexamethasone pill, and exposure to radiation from the CT scan. The study will be completed over the course of 2-3 visits in one months timeframe.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-876-5785
washoliv@musc.edu

MYELOMATCH, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI MyeloMATCH Clinical Trials

Date Added
August 11th, 2025
PRO Number
Pro00146515
Researcher
Praneeth Baratam

List of Studies

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

This phase 2 study is screening patients who may have acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study is a non-treatment protocol and the first step of taking part in myeloMATCH, which is a clinical trial. The main purpose of the study is to see if testing on patient's bone marrow and blood results in finding certain biomarkers that will qualify participants for the treatment study or for Standard of Care (SOC) therapies. The study will enroll approximately 5000 patients. The study has two periods, initial and post-treatment screening. It takes about four days for the study doctor to receive the screening results and the patient's first treatment assignment in myeloMATCH. Patients will complete post-treatment screening after their participation in treatment trials or SOC therapies. It will take about 11 days for the study doctor to receive these results and decide their next treatment assignment. Further testing may match patients with myeloMATCH substudies in the future. The main risk is that biomarker test results may be wrong. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

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

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Date Added
August 11th, 2025
PRO Number
Pro00146236
Researcher
Jonathan Alexander

List of Studies

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

This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.

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

A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs. Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naive Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Related Head and Neck Squamous Cell Carcinoma (HNSCC)

Date Added
August 8th, 2025
PRO Number
Pro00145400
Researcher
John Kaczmar

List of Studies


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

The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA), given intravenously ("IV;" into the vein) compared to pembrolizumab (KEYTRUDA) alone for those with unresectable recurrent or metastatic head and neck cancer and high risk papillomavirus infection. "Investigational" means the combination of the study vaccine and pembrolizumab being tested has not been approved by the US Food and Drug Administration (FDA) nor any other Health Authority.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

A non-interventional, post-authorisation safety study of patients treated with efgartigimod alfa

Date Added
August 7th, 2025
PRO Number
Pro00145070
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Non-interventional
Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.
Enrolment of patients will be over at least a 5-year period. The follow up of patients will continue for 5 years from the time the last patient has been enrolled. Patients will be followed up regardless of whether they continue or discontinue efgartigimod.

Institution
MUSC
Recruitment Contact
Alison Line
8437922845
line@musc.edu

Sharing Our Stories: The Realities of Living with Ehlers Danlos Syndromes

Date Added
August 7th, 2025
PRO Number
Pro00144466
Researcher
Michelle Nichols

List of Studies


Keywords
Autoimmune disease, Chronic Fatigue, Genetics, Joint, Non-interventional, Pain, Rheumatoid
Summary

Sharing Our Stories: The Realities of Living with Ehlers Danlos Syndromes (EDS) is a research study to help better understand what it is like to live with EDS. Adults with EDS will complete a one-time video interview with a member of the research team. We hope to better understand the challenges adults with EDS face and learn from them things that make it more difficult and easier to receive care, what their needs are and recommendations for improving an earlier diagnosis, care, and treatment.

Institution
MUSC
Recruitment Contact
Michelle Nichols
843-876-6463
nicholmg@musc.edu

A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors

Date Added
August 7th, 2025
PRO Number
Pro00143120
Researcher
John Kaczmar

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 BNT317. "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 safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. Researchers will continue to follow-up with patients long-term.

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



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