A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


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

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

Date Added
July 30th, 2020
PRO Number
Pro00097539
Researcher
Theodore Gourdin

List of Studies


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

This study is for a patient that have received previous treatment for renal cell carcinoma. During this study, patients will be randomized to get the investigational drug, MK-6482, or a standard of care drug, everolimus. This is a study to test if MK-6482 or the standard of care drug works better for patientsr type of prostate cancer. MK-6482 is considered experimental. "Experimental" means that the study drug is currently being tested for patientsr type of cancer. It has not been approved by certain health authorities, such as the United States (U.S.) Food and Drug Administration (FDA) to treat prostate cancer. Where as, everolimus, has been an approved standard of care chemotherapy by the FDA.
Participants can expect to be in this study for 4 years.

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Date Added
July 1st, 2020
PRO Number
Pro00095489
Researcher
Michelle Hudspeth

List of Studies


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

This study is for patients that are getting an allogeneic hematopoietic stem cell transplantation (allo-HSCT) from an unrelated donor for a hematologic malignancy, (cancers that affect the blood and/or lymphatic system). The investigational drug in this study is Vedolizumab. This purpose of this study is to investigate the safety and effectiveness of Vedolizumab compared to placebo (dummy drug), for prevention of intestinal acute graft versus-host disease (aGvHD) in patients undergoing allo-HSCT. GvHD occurs when particular types of white blood cell (T cells) in the donated cells (the graft) attack patients own body cells.

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

PREEMPT CRC: PREvention Employing a Multiomics Plasma-based Test for ColoRectal Cancer

Date Added
June 22nd, 2020
PRO Number
Pro00099252
Researcher
Don Rockey

List of Studies


Keywords
Aging, Cancer/Other, Colonoscopy, Digestive System, Disease Prevention, Men's Health, Prostate
Summary

The Sponsor of this research study is trying to develop a new experimental diagnostic blood test that may help detect colorectal cancer and other diseases. A diagnostic test identifies a specific disease or condition. Experimental means the test has not received approval by the United States Food and Drug Administration (FDA) for sale.
The main goal of this research study is to collect health information and blood samples from people who are going to have a standard-of-care screening colonoscopy. The blood samples along with other health information from patients who take part in the study may help the Sponsor develop new diagnostic tests that may help detect cancer or other diseases in other patients in the future.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
bickfome@musc.edu

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Date Added
May 28th, 2020
PRO Number
Pro00096416
Researcher
John Wrangle

List of Studies


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

This study is for patients who have been diagnosed with solid tumor malignancy with KRAS G12C mutation. The investigational drug used in this study is MRTX849. The purpose of this study is to see if patients with cancer with a KRAS G12C mutation will benefit from treatment with MRTX849, what side effects occur and how often they occur and to see how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. Participants can expect to be in this study for as long as the disease does not get worse.

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

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
April 28th, 2020
PRO Number
Pro00096818
Researcher
John Kaczmar

List of Studies


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

This study is for patients that have been diagnosed with PD-L1 Positive Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, for people with this type of cancer that cannot be treated with surgery or radiation treatment and has not been treated for cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent).The investigational drug (not approved by the FDA) in this study is GSK3359609. The purpose of this research study is to find out if GSK3359609 combined with pembrolizumab works better than the single drug pembrolizumab. Participants can expect to receive treatment for about 3 years and be in follow-up for the rest of their life.

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

SCTR / MUSC COVID-19 Biorepository

Date Added
April 16th, 2020
PRO Number
Pro00098961
Researcher
Patrick Flume

List of Studies


Keywords
COVID-19, Coronavirus, Infectious Diseases, Men's Health, Non-interventional, SARS-CoV-2, Women's Health
Summary

The Medical University of South Carolina (MUSC) is developing a COVID-19 biorepository which will contain blood, urine, and other bodily fluids along with relevant medical information from individuals evaluated, exposed to, or treated for COVID-19. To learn from this pandemic ,and to develop treatments and strategies to better prepare and avert future pandemics we must study the disease and its effects. The clinical specimens in the biorepository will be available for investigators to use for future research. Compensation is provided for participation in this project for eligible participants.

Institution
MUSC
Recruitment Contact
Lauren Card
843-729-4394
coordinator@musc.edu

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Date Added
March 10th, 2020
PRO Number
Pro00095193
Researcher
Michael Lilly

List of Studies


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

This study is for patients who are 18 years and older that have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC).The investigational drugs in this study are Nivolumab and Ipilimumab.The purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability of different dosing regimens containing nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel plus prednisone or prednisolone in participants with metastatic castration-resistant prostate cancer (mCRPC).Duration of this study will take approximately 24 months.

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

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy

Date Added
March 9th, 2020
PRO Number
Pro00095232
Researcher
Thomas Keane

List of Studies


Keywords
Cancer, Drug Studies, Men's Health
Summary

This study is for patients who have been diagnosed with localized and locally advanced high-risk prostate cancer who are planned for radical prostatectomy (surgical removal of the whole prostate and surrounding tissue). This is a research study to find out if experimental medication called apalutamide (also known as JNJ-56021927) plus androgen deprivation therapy (ADT) , also known as hormone therapy, is safe and could improve the results of surgery and delay the time to when prostate cancer tumors spread to other parts of the body.

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

A Phase I, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 3654 in patients with Intermediate-2 or High-Risk Primary or Secondary Myelofibrosis

Date Added
February 25th, 2020
PRO Number
Pro00096184
Researcher
Robert Stuart

List of Studies


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

This study is for subjects that have intermediate-2 or high risk, primary or secondary Myelofibrosis for which standard therapy has proven ineffective, for which their body cannot tolerate the standard therapy, or for which there is no standard therapy. This study is testing an "investigational" (not yet FDA approved drug) study drug called TP-3654. The primary purpose of this study is to evaluate the safety of TP-3654 at different doses to find out what effects, if any, it has on people. The subject may remain in the study for up to 1 year. They may receive additional treatment beyond 1 year if they are tolerating and showing benefit from the treatment.

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



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