Prospective ctDNA Monitoring in Exceptional Responders to Immunotherapy: A Pilot Study

Date Added
August 8th, 2022
PRO Number
Pro00117604
Researcher
John Kaczmar

List of Studies


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

This study is for subjects that have been diagnosed with advanced cancer. The purpose of this study is to find subjects with advanced cancer that had an exceptional disease response (improvement) while being treated with standard immunotherapy agents. This study will monitor their progression through a series of blood draws. Subjects will either continue immunotherapy or have completed immunotherapy. Participation in the study will take about 6 visits over a period of about 2 years. During this time the study team will follow your care by clinic visit, phone contact and/or medical record review every three months to collect information on the status of your cancer. This is not a treatment study.

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

A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy

Date Added
July 26th, 2022
PRO Number
Pro00118909
Researcher
Theodore Gourdin

List of Studies


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

This study is for subjects that have metastatic urothelial cancer (mUC). Metastatic means your cancer has spread outside the area where it started and has spread to distant parts or organs of the body. This study is testing an "investigational" (not yet Food and Drug Administration, FDA, approved drug) study drug called sacituzumab govitecan. Sacituzumab govitecan is given intravenously, through IV. The primary purpose of this study is to evaluate treatment with sacituzumab govitecan alone and in combination with other treatments namely cisplatin, avelumab and pembrolizumab improves tumor shrinkage. They are antibodies made in a laboratory that blocks signals that the cancer sends to quiet your immune system. By blocking that signal your immune system can see the cancer as foreign and fight it. The subject may remain in the study for 18 months. They may receive additional treatment beyond 18 months if they are tolerating and showing benefit form the treatment.

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

T-reg function changes: a novel immune regulatory effect underlying benefit of statin use on lethal prostate cancer

Date Added
June 21st, 2022
PRO Number
Pro00120567
Researcher
Michael Marrone

List of Studies

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

This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.

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

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (RELATIVITY 098)

Date Added
June 1st, 2022
PRO Number
Pro00116818
Researcher
Daniel Reuben

List of Studies


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

This study is for patients that have been diagnosed with stage III-IV Melanoma after a complete resection (no evidence of disease). The investigational drug in this study is relatlimab in combination with nivolumab. Investigational means the drug is not approved by the United States Food and Drug Administration (US FDA). Participants will be assigned to receive relatlimab with nivolumab in a fixed dose combination (FDC, both drugs in a single vial) or nivolumab alone, administered by intravenous (IV) infusion, meaning the drug is a solution given through a vein. The infusion is planned to take 30 minutes. Neither the participants or study doctor will know what is being administered.

This study is designed to explore if treating stage III-IV resectable melanoma patients with this combination, after they have surgery to remove all tumors, will reduce the probability of having progressive disease when compared to nivolumab alone, as well as to assess the possible side effects that this combination therapy might have. Participants can expect to be on this study for a minimum of 6 years.

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

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Date Added
May 11th, 2022
PRO Number
Pro00117937
Researcher
Paul O'Brien

List of Studies


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

This study is for participants that have colorectal cancer that has been treated before, spread to other parts of the body and they test positive for a protein called PD-L1. PD-L1 is a protein that helps keep T cells from killing other cells, including cancer cells. This study drug (MK-4280A) is used to block this protein so the "brakes" on the immune system are released and the ability of T cells to kill cancer cells is increased. MK-4280A is a mixture of 2 drugs: MK-4280 (favezelimab) and MK-3475 (pembrolizumab also called pembro). MK-4280A has not been approved by the United States Food and Drug Administration (FDA). This purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) and to compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). Participants will be randomized to one of two groups. Group 1 will get MK-4280A and Group 2 will get a standard treatment. This study has 3 phases: Screeing (about 1 month), Treatment (depends on which drug the participant gets, how well their cancer is controlled, and how they are feeling) and Follow-up (1 visit 30 days after the last dose of study drug, then every 9 weeks, then the study team will contact you every 12 weeks). Participants may experience certain side effects and discomforts from taking the study drug. Because the study drug is experimental, all the side effects may not be known.

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

An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)

Date Added
April 26th, 2022
PRO Number
Pro00118851
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with multiple myeloma or lymphoma that has returned after standard therapy or that are not able to tolerate the standard therapy. This study is testing an "investigational" (not yet Food and Drug Administration (FDA) approved) radioactive study drug called CLR 131. This study will find out if the drug is safe and tolerable. The subject will be given the study drug on days 1, 15, 57, and day 71 of the study. At any given visit, the subject may undergo procedures, such as a physical exam, heart monitoring, blood draws, and an ECG (electrocardiogram). The subject may remain in the study for up to approximately 5 to 8 months.

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

RADIANCE TRIO Continued Access Protocol (TRIO CAP) A study of the ReCor Medical Paradise System in Clinical Hypertension

Date Added
April 26th, 2022
PRO Number
Pro00118326
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Men's Health, Women's Health
Summary

The purpose of this study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the US Food and Drug Administration (FDA). Renal denervation is a procedure where a catheter is placed inside the blood vessels (renal arteries) that go to the kidneys. Ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels. This is a continued access protocol meaning studies have already been done using this device.

This study is for participants who take 3 or more high blood pressure medications but continue to have high blood pressure. This is a five year study consisting of in person visits at screening, baseline, pre procedure testing, procedure and visits at 1,2,3,4,5,6,12,24,36,48 and 60 months. Study related testing includes BP measurements including 24 hour blood pressure readings, electrocardiograms (ECG), blood work, urine studies, and CT scans. Risks associated with this study include procedure risks such as pain, bleeding or bruising at the catheter insertion site. There are other study related risks such as risks of blood draws, radiation risk associated with the CT scan and loss of confidentiality.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)

Date Added
March 29th, 2022
PRO Number
Pro00116642
Researcher
Theodore Gourdin

List of Studies


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

The study is for patients that have been diagnosed with invasive urothelial carcinoma (cancer of the bladder [UBC] or cancer of the upper urinary tract [UTUC]), and had the cancer removed surgically. The investigational drug used in this study is infigratinib or placebo. The main purpose of this study is to to determine whether patients who have undergone surgery to remove invasive urothelial cancer that has a genetic abnormality (changes in tumor's DNA) in the Fibroblast Growth Factor Receptor 3 (FGFR3) gene who receive the investigational drug infigratinib for one year remain cancer free compared with those who recThe total length of time you will participate in the study depends on how you respond to the study drug and how long other participants remain in the study. After this study is completed, you will be offered to participate in a long-term follow up study. ive placebo for one year. Participants can expect to be in this study for up to 4 years.

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

Exploratory clinical trial of topical Imiquimod 5% cream as window-of-opportunity monotherapy for early-stage oral cancer

Date Added
March 15th, 2022
PRO Number
Pro00119074
Researcher
Angela Yoon

List of Studies

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

This study is for subjects that have been diagnosed with oral cancer. The investigational drug in this study is Imiquimod. The purpose of this research study is to find out what effects, good and/or bad, topical application of the study drug Imiquimod will have on you and your oral cancer. Subjects can expect to be in this study for up to 1 month.

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

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma

Date Added
February 23rd, 2022
PRO Number
Pro00116243
Researcher
Hamza Hashmi

List of Studies

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

This study is for subjects with multiple myeloma who have not responded to their most recent treatment. The study is testing an "investigational" (not yet FDA approved drug) study drug called Teclistamab. The primary purpose of this study is to see how teclistamab in combination with daratumumab (Tec-Dara) compares to either daratumumab, pomalidomide, and dexamethasone (DPd) or daratumumab, bortezomib (VELCADE), and dexamethasone (DVd) for treating participants with multiple myeloma who have not responded to their most recent treatment. The study will last for approximately 6 years, but subjects at MUSC can expect to be in the study for approximately 1 and a half years. The duration of the subject's participation will depend on how you respond to the study treatment.

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



-- OR --