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 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

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

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 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Date Added
April 2nd, 2025
PRO Number
Pro00142948
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health
Summary

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.

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



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