A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study) Save

Date Added
September 7th, 2019
PRO Number
Pro00090813
Researcher
Michael Lilly

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

This study is for patients who have been diagnosed to have metastatic Castration-resistant Prostate Cancer (mCRPC). The purpose of this study is to find out if experimental medication called olaparib in combination with approved drug called abiraterone, will work and be safe for the treatment of the disease (mCRPC). Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. Olaparib (tradename Lynparza™) is approved, by the US Food and Drug Administration (FDA) and other countries for the treatment of certain types of ovarian cancer and breast cancer. Abiraterone is already an approved medication for the treatment of some subjects with prostate cancer. This medication is indicated in combination with prednisone or prednisolone for the treatment of mCRPC. The research study is planned to go on for approximately 4 years, with visits lasting three to six hours each. Olaparib, abiraterone, and prednisone are all taken orally.

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

A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer Save

Date Added
September 1st, 2019
PRO Number
Pro00083993
Researcher
Whitney Graybill

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

The purpose of this study is to determine if adding the investigational drugs (TSR-042 and Niraparib) to Standard Of Care delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back). Once eligibility is determined, participants will begin with one of two treatment periods. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. The first treatment period is the chemotherapy treatment period, and the second one is the maintenance treatment period. It is not known how long participation in this study may last.
The Sponsor and Study Doctors cannot and do not guarantee or promise that participants will receive any benefits from this study. There is a chance by taking the study drug participants cancer may not return or the return of cancer may be delayed. It is not known whether participants would benefit from the Study Drug. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. Therefore, participants may not get any direct benefit from taking part in this study. However, what is learned in this study may help in the treatment of ovarian cancer for women around the world and may advance scientific knowledge.

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

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment in Patients with Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Save

Date Added
August 28th, 2019
PRO Number
Pro00086110
Researcher
Daniel Reuben

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, good or bad, of tislelizumab (also known as BGB-A317) plus chemotherapy against placebo (an inactive substance) plus chemotherapy for adults with locally advanced recurrent or metastatic esophageal squamous cell carcinoma to find out which is better. Subjects may continue study treatment during their participation in the study as long as there is no worsening of disease and they don't have intolerable side effects from the study treatment

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

A Phase II Study of Palbociclib (PD-0332991) in Combination with Ibrutinib in Patients with Previously Treated Mantle Cell Lymphoma Save

Date Added
August 27th, 2019
PRO Number
Pro00091524
Researcher
Irl Greenwell

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

This study is for subjects that have been diagnosed with mantle cell lymphoma (MCL) and have already received at least one form of treatment. This study will evaluate the effects, good and bad, of the study drugs palbociclib and ibrutinib in your type of cancer. The purpose of this study is to study the effects of an investigational combination of ibrutinib and a drug called palbociclib on MCL. The subject will be in the study for as long as you do not experience any unacceptable side effects and your cancer does not become worse.

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

A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors Save

Date Added
August 13th, 2019
PRO Number
Pro00090771
Researcher
Daniel Reuben

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to explore any changes in tumors after adult subjects (ages 18+) who have advanced pancreatic or colorectal cancer receive an immunotherapy drug, called BMS-813160, alone or together with another immunotherapy drug, called nivolumab or chemotherapy. BMS-813160 and nivolumab belongs to a class of drugs called immunotherapies. ?Immuno' in ?immunotherapy' refers to the immune system. The immune system is the body's natural defense against illnesses like colds, infections, and cancer. There is no defined length of time for this study. The exact time commitment will depend on several factors, such as availability to come for appointments, cancer's response to the study drugs, reaction to the study drugs, and the sponsor's decision of whether to continue the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9300
hcc-clinical-trials@musc.edu

A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Save

Date Added
July 28th, 2019
PRO Number
Pro00088773
Researcher
Vanessa Hinson

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Keywords
Drug Studies, Parkinsons, Stage III
Summary

IPX203 is an investigational extended-release (i.e. releases drug more slowly) capsule formulation of carbidopa-levodopa (CD-LD) administered orally (by mouth). "Investigational" means that IPX203 is being tested and has not been approved for marketing.

IPX203 is being investigated to determine whether the drug is safe and potentially has a better effect than currently approved IR CD-LD. If successful, the drug could possibly improve the daily control of motor symptoms in people with Parkinson's disease.

IPX203 is provided as a capsule containing 140 mg LD and 35 mg CD. The study doctor may adjust the IPX203 dosing regimen based on your response to the study drug during the 4 week dose conversion period. Your study doctor will instruct you on the dose of IPX203 or IPX203 placebo that you will receive during the 13-week portion of the study.

Your total participation time in the study will be approximately 24 weeks (6 months), which includes 4 weeks for your initial assessment (screening) period to determine if the trial is suitable for you.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

A Phase II Study of Durvalumab (MEDI 4736) with Radiotherapy for the adjuvant treatment of Intermediate Risk Head and Neck Squamous Cell Carcinoma Save

Date Added
July 23rd, 2019
PRO Number
Pro00089876
Researcher
John Kaczmar

List of Studies

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

This study is for patients who have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (SCCHN) and will need additional treatment following surgery. The investigational drug in this study is Durvalumab. The purpose of this study is to investigate other drugs that may be combined with radiation to treat SCCHN. The study focuses on determining whether durvalumab combined with radiation will have improved 3-year disease free survival compared to historical control. Participants can expect to be in this study for 5 years.

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

A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin Save

Date Added
July 23rd, 2019
PRO Number
Pro00089429
Researcher
Robert Grubb

List of Studies

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

This study is for patient that have bladder cancer and have been treated with BCG (Bacillus Calmette-Guerin), but the cancer has returned after treatment(s). This research study is designed to test if an investigational agent named BC-819 can prevent or delay tumor recurrence in non-muscle invasive bladder cancer patients who have become unresponsive to BCG treatment.
The primary objective is to determine, for the patients with baseline CIS:The proportion that achieves a complete response after treatment with inodiftagene vixteplasmid Participants can expect to be in this study for102 weeks.

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma Save

Date Added
July 18th, 2019
PRO Number
Pro00087838
Researcher
John Kaczmar

List of Studies

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

This study is for patients that have been diagnosed with with resectable High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The investigational drug used in this study is Pembrolizumab. The purposes of this study are to: determine how well pembrolizumab keeps the cancer from coming back or spreading as compared to placebo, determine if giving pembrolizumab after surgery and radiation helps patients live longer, and to test the safety of the study drug and see how patients' bodies handle it. Participants can expect to be in this study for about 8 years. This includes the time that participants will be on study drug and in follow up to see if the cancer has come back or spread.

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

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy Save

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies

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Keywords
Body Composition, Cardiovascular, Drug Studies, Healthy Volunteer Studies, HIV / AIDS, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu

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