Randomized Phase II study of the Addition of Targeted Therapeutic Agents to Tafasitamab-based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Date Added
July 10th, 2025
PRO Number
Pro00146204
Researcher
Brian Hess

List of Studies


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

This is a randomized, phase II study for patients with Relapsed/Refractory Large B-Cell Lymphoma. The purpose of this study is to determine how long people with Large B-Cell Lymphoma can live without their disease getting worse when treated with two different combinations of cancer drugs. One group will get tafasitamab + lenalidomide + tazemetostat, and the other group will get tafasitamab + lenalidomide + zanubrutinib. The researchers want to see which combination works better. They also want to figure out the best and safest dose of each drug combination to use in future studies. Tafasitamab is a lab-made antibody that helps the immune system find and attack cancer cells. Lenalidomide is a drug that boosts the immune system and helps fight cancer. Tazemetostat is a drug that blocks a protein (EZH2) that helps cancer cells grow. Zanubrutinib is a drug that blocks another protein (BTK) involved in cancer cell survival. The treatment period may last approximately 1 year and the follow up period may last up to 3 years.

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

Randomized Phase 2 Trial of Sacituzumab Govitecan With or Without Pembrolizumab in First-line Metastatic PD-L1-negative TNBC

Date Added
July 8th, 2025
PRO Number
Pro00145388
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients with PD-L1-negative metastatic TNBC, who have not received prior therapy for metastatic breast cancer and who have not received a prior PD-1/L1 inhibitor.

Subjects can remain on study for as long as they are benefitting from treatment - there are no set number of visits required to participate in this study. Sacituzumab govitecan and pembrolizumab are taken via intravenous (IV) infusion. Risks include decrease in white blood cell count, anemia, nausea, joint pain, and headache.

The U.S. Food and Drug Administration (FDA) has approved Sacituzumab govitecan for metastatic triple-negative breast cancer, however, it is considered experimental in this study because it is currently only approved for patients who have had more treatment than patients eligible to participate in this study. The FDA has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is also considered experimental in this study because it is not currently approved for patients with PD-L1 negative cancer.

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

A RANDOMIZED PHASE III CLINICAL TRIAL FOR THE ADDITION OF DOCETAXEL TO ANDROGEN RECEPTOR PATHWAY INHIBITORS IN PATIENTS WITH METASTATIC CASTRATION SENSITIVE PROSTATE CANCER AND SUBOPTIMAL PSA RESPONSE (TRIPLE-SWITCH)

Date Added
June 20th, 2025
PRO Number
Pro00144119
Researcher
Kevin Becker

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer. Subjects can expect to remain in the study for up to 39 months or longer. There will be a total of 16 enrolled locally. The study is set to enroll subjects for 39 months.

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

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma

Date Added
June 3rd, 2025
PRO Number
Pro00144090
Researcher
Aaron Cunningham

List of Studies

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

This study is for patients with resectable oligometastatic pulmonary osteosarcoma. The purpose of this phase three study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma. The risks from this study are the usual risk of surgery such as bleeding, infection, injury to chest area, and pain after surgery. There is also the risk that additional surgery may be required to remove all cancer from the patient's lung. People in this clinical trial will receive surgery as the study therapy. The length of time surgery lasts can vary. After treatment, the patient will have follow-up examinations and medical tests.

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

Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Trial

Date Added
May 20th, 2025
PRO Number
Pro00143653
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with ovarian cancer who are taking bevacizumab. This study is testing two investigational drugs called nelfinavir and hydroxychloroquine. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of cancer. The primary purpose of this study is to see if these two medications in combination with bevacizumab are safe and effective in ovarian cancer. These drugs will be given by mouth. Participants in this study can expect to be in this study for 6 months for data collection, but may continue on the study medications longer if seeing benefit.

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

Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

Date Added
May 15th, 2025
PRO Number
Pro00144480
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to compare the usual treatment alone to the usual treatment plus nivolumab. This study seeks to find if this approach is better or worse than standard of care for colon cancer. Treatment and follow up for this study may be up to 3 years. The procedures include CT or MRI scans and chemotherapy. Risks include diarrhea, nausea, vomiting, hair loss, anemia, sores in mouth, and muscle weakness. You 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

CONQUEST: Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis

Date Added
May 13th, 2025
PRO Number
Pro00135916
Researcher
Faye Hant

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma
Summary

The CONQUEST study is a clinical trial for people with systemic sclerosis associated interstitial lung disease (SSc-ILD). The goal of the research study is to help potentially uncover new SSc-ILD treatment options. The study is sponsored by The Scleroderma Research Foundation and is currently working with 2 pharmaceutical companies to provide the investigational medications (Amlitelimab, a subcutaneous injection/shot and BI 1015550/Nerandomilast, a tablet taken by mouth). Study participation involves a main study which is collecting general information about your scleroderma health and well being and at the same time, a treatment study that is specific to the investigational drug that you are assigned.

An investigational or study drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study the ID will be compared with a placebo (dummy drug). The placebo will be a look like the ID but does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of the ID or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know if you are taking a study drug or placebo but you will know what treatment study you are assigned (Treatment Study A with Amlitelimab or Treatment Study B with BI 1015550/Nerandomilast).

Participation in the overall study will be approximately 60 weeks (4 weeks
Screening, 52 weeks Treatment Period, and 4 weeks Follow-up with visits to the MUSC main campus. Study visits are much like the visits that you have with our Rheumatologist as part of your routine care such as: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as being asked to complete surveys/questionnaires.

Compensation is available with participation.

Institution
MUSC
Recruitment Contact
Miranda Irvin
843-792-8613
sclerodermaresearch@musc.edu

A randomized, controlled trial of varenicline for e-cigarette cessation

Date Added
May 9th, 2025
PRO Number
Pro00142969
Researcher
Benjamin Toll

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This is a smoking cessation study which is examining varenicline for use in reducing or quitting e-cigarettes. Half of the participants will receive a placebo pill and half will receive varenicline. All participants will be asked to complete daily, brief REDCap EMA diaries (to report e-cigarette use, other tobacco use, and record videos of medication taking) and attend research visits every 3 weeks (i.e., weeks 3, 6, 9, 12) to complete additional assessments and receive compensation for doing so.

Institution
MUSC
Recruitment Contact
Rachel Christian
(843)737-1516
chrisrac@musc.edu

LOTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER

Date Added
May 1st, 2025
PRO Number
Pro00144117
Researcher
Abirami Sivapiragasam

List of Studies

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

This study is for subjects that are post-menopausal women that have been diagnosed with early-stage, low molecular risk breast cancer. Subjects are expected to remain in the study for 60months. There will be a total of 25 subjects enrolled locally.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc0clinical-trials@musc.edu



-- OR --