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

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 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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants with Opioid Use Disorder (MK-4305-098)

Date Added
July 18th, 2025
PRO Number
Pro00146129
Researcher
Allison Wilkerson

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

This research is being done to see if the drug suvorexant is effective as treatment for insomnia in people who have opioid use disorder and who are utilizing stable medications for opioid use disorder (MOUD). It is a 13-week study, and the study drug will be compared to a placebo.

Institution
MUSC
Recruitment Contact
Kyle Williams
843-876-6399
kyw210@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 Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Date Added
June 24th, 2025
PRO Number
Pro00144995
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to find out if adding a drug called ribociclib to the usual hormone therapy drugs can lower the chance of your breast cancer coming back again. This study is for patients with locoregional, recrrent, resected hormonone receptor positive HER2 negative breast cancer. Endocrine therapy has already been approved by the FDA for your type of cancer. Ribociclib has already been approved by the FDA for your type of cancer that has not been removed by surgery or has spread to other parts of the body.

Receiving ribociclib with endocrine therapy is still being studied and to yet approved by the FDA. Ribociclib is taken as a pill and endocrine therapy is taken as an injection. Participants will receive ribociclib with endocrine therapy for up to 3 years and can receive endocrine therapy alone for an additional two years after stopping ribociclib. Participants can remain on the study for up to 5 years.

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



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