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

A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy With Or Without Androgen Deprivation Therapy In Oligometastatic Prostate Cancer (NRG PROMETHEAN)

Date Added
June 6th, 2025
PRO Number
Pro00144873
Researcher
Brian Lally

List of Studies

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

The purpose of this study is to determine if we lower the chance of your prostate cancer growing or spreading by adding the drug relugolix to the usual radiation therapy? This study seeks to find if this approach is better or worse than standard of care for prostate cancer.

Treatment and follow up for this study may be up to 5 years. The procedures include blood samples, PET scans, hormone therapy and radiation therapy. Risks include diarrhea, back pain, weight gain, and headache. 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

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

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

Perioperative Versus Adjuvant Systemic Therapy in Patients with Resectable Non-Small Cell Lung Cancer- Prospect Lung

Date Added
April 30th, 2025
PRO Number
Pro00143693
Researcher
Barry Gibney

List of Studies


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

This is a Phase III study is for patients that have been diagnosed with with early-stage non-small cell lung cancer. The primary purpose of this study is to see if there is a difference in overall survival rate in patients changes based on when they start their drug treatment, either before or after surgical intervention. Participants in this study can expect to be followed for up to 10 years. This study has two groups and a computer will be used to assign study groups. Participants will be randomly assigned to receive either neoadjuvant therapy followed by surgery and adjuvant therapy, or surgery followed by adjuvant therapy. This is called randomization. Patients will have an equal chance of being in either group, similar to flipping a coin.

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

A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide

Date Added
April 30th, 2025
PRO Number
Pro00141089
Researcher
Kimberly Green

List of Studies

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

This is a randomized, Phase 3, active-controlled, parallel, multicenter, interventional, open-label study in participants with relapsed or refractory multiple myeloma who have received 1 to 4 prior lines of therapyincluding an anti-CD38 mAb and lenalidomide.An IRC will be commissioned to adjudicate participants' response to treatment and disease progression.An IDMC will be commissioned to review safety periodically and efficacy at prespecified interim analysis
timepoints.The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Screening Phase will be up to 28 days before randomization. The Treatment Phase will extend from C1D1 until confirmed disease progression, death, intolerable toxicity, withdrawal of consent, or discontinuation of all study treatment (whichever occurs first). Participants can continue therapy with talquetamab/teclistamab (as appropriate) for up to 26cycles if they have no sign of PD or toxicity. Following the Treatment Phase, participants will continue in the Follow-up Phase until death, withdrawal of consent, loss to
follow-up, orend of the study, whichever occurs first. The EOS is considered as completion of the final OS analysis, which will occur after approximately 311 death events for each comparison.

Institution
MUSC
Recruitment Contact
Shanta Salzer
(843)792-9300
salzers@musc.edu

Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Date Added
April 22nd, 2025
PRO Number
Pro00144157
Researcher
William Albergotti

List of Studies

Keywords
Cancer/Skin, Drug Studies, Men's Health, Stage III, Stage IV, Women's Health
Summary

This phase III study evaluates whether cemiplimab can shrink or prevent the return of cancer when combined with the usual approach for skin cancer more effectively than the usual approach alone. This study will enroll adults diagnosed with stage III/IV cutaneous squamous cell carcinoma. If eligible to participate in this study participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery used to treat this type of cancer. After surgery, they may get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before surgery every 3 weeks for up to 12 weeks. They may also receive radiation after surgery depending on the tumor tissue results from surgery. If treated with cemiplimab before surgery, then tumor tissue results will also determine whether or not they receive cemiplimab every 6 weeks for up to 24 weeks, after surgery, and radiation if given. Participants will be asked to complete quality of life questionnaires to understand how they are feeling during treatment and the effects of the treatment. Participants will be checked for sides effects 3 to 4 months for 2 years after treatment. After that, every 6 months for 1 year and then annually. The main risks are tiredness, diarrhea or constipation, nausea, rash or itching, change in thyroid function, and risk of progression of the cancer to require earlier surgery or to become inoperable. Alternatives to this treatment is standard of care surgery and radiation. The study benefit is cemiplimab may help in shrinking or stabilizing this type of skin cancer.

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

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY

Date Added
March 28th, 2025
PRO Number
Pro00141609
Researcher
Abirami Sivapiragasam

List of Studies

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

The study is designed for patients with Estrogen Receptor (ER) positive, HER2-negative advanced breast cancer resistance to prior adjuvant endocrine treatment. The purpose of the study is to determine the effectiveness of Giredestrant compared with Fulvestrant in combinationof CDK4/6i (Palbociclib, Ribociclib and Abemaciclib). The study drug being utilized is giredestrant. The FDA approved drugs will also be utilized: Zoladex and Lupron (LHRH - Luteinizing hormone-releasing hormone agonists) drugs; as well as, Palbociclib, Ribociclib , Fulvestrant, and Abemaciclib.

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



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