A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Save

Date Added
September 25th, 2018
PRO Number
Pro00080886
Researcher
Michael Lilly

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Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The purpose of this research study is to determine the effectiveness and safety of niraparib used in combination with JNJ-63723283 in the treatment of subjects with advanced prostate cancer. The study medication, niraparib and JNJ-63723283 are given in cycles, with each cycle lasting 28 days. You will continue study medication for as long as your disease does not appear to be getting worse based on assessments by your doctor.

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

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer Save

Date Added
August 28th, 2018
PRO Number
Pro00080821
Researcher
Theodore Gourdin

Silhouette
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies
Summary

The purpose of this study is to evaluate Nivolumab or Nivolumab plus Experimental Medication BMS-986205 with or without BCG (bacillus Calumette-Guerinin) BCG-Unresponsive non-muscle invasive Bladder Cancer. You will be randomized (assigned by chance) to receive treatment in either Arm A, Arm B, Arm C or Arm D. Arm A is Nivolumab alone, Arm B is Nivolumab and BCG (Bacille Calmette Guerin), Arm C is Nivolumab with IDO1 Inhibitor (BMS-986205), and Arm D is Nivolumab with IDO1 Inhibitor (BMS-986205) and BCG . An IDO1 inhibitor (such as BMS-986205) is designed to block the function of a protein (called an enzyme), called IDO1 within the body.Blocking the IDO pathway may help the immune system to fight abnormal cancer cells in the body.This is an open label study which means both you and your doctor will know which treatment you are receiving. You will take your assigned study medication as assigned based on your treatment arm for 52 weeks

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

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Save

Date Added
August 21st, 2018
PRO Number
Pro00075705
Researcher
Thomas Keane

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Cardiovascular, Drug Studies, Prostate
Summary

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

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

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer Save

Date Added
July 18th, 2018
PRO Number
Pro00080775
Researcher
David Marshall

Silhouette
Keywords
Cancer, Cancer/Genitourinary
Summary

Patients will be randomized to 1 of 2 arms:
ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo orally once daily on days 1-30. Treatment repeats every 30 days for up to 6 courses over 6 months in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive oral apalutamide on Days 1-30. Treatment repeats every 30 days for up to 6 courses over 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly thereafter.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Save

Date Added
June 12th, 2018
PRO Number
Pro00077321
Researcher
Theodore Gourdin

Silhouette
Keywords
Cancer/Genitourinary, Drug Studies
Summary

The purpose of this study is to determine if CB-839 (an "investigational" drug), given together with cabozantinib (an "approved" drug) is able to stop or reduce the rate of cancer growth in patients with advanced or metastatic renal cell carcinoma better than cabozantinib alone. This study will also look at any possible effect that CB-839 in combination with cabozantinib may have on your cancer.

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

A Phase III Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-Containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303) Save

Date Added
May 7th, 2018
PRO Number
Pro00077046
Researcher
Theodore Gourdin

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

This study evaluates the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

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

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma (FRACTION-RCC) Save

Date Added
December 12th, 2017
PRO Number
Pro00070527
Researcher
Theodore Gourdin

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney
Summary

The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced renal cell carcinoma.

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

A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin (ASG-22CE) in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer Save

Date Added
December 12th, 2017
PRO Number
Pro00072223
Researcher
Theodore Gourdin

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

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

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

A Phase 1b, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with Cisplatin Plus Gemcitabine and PEGPH20 in Combination with Atezolizumab and Cisplatin Plus Gemcitabine Compared with Cisplatin Plus Gemcitabine in Subjects with Previously Untreated Unresectable, Locally Advanced or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma Save

Date Added
October 24th, 2017
PRO Number
Pro00071570
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

The purpose of this study is to study test investigational drugs PEGPH20 and Atezolizumab in combination with the current standard of care medications Cisplatin and Gemcitabine.

Subjects are being asked to participate in this study because they are/have intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma which are types of cancers associated with the liver or biliary system. The study is sponsored by Halozyme.

This study involves the adiminstration of an invetigational drug (not approved by the FDA) PEGPH20 in order to determine what a safe dose is when given with Cisplatin and Gemcitabine, what the side effects are, and whether or not it will help treat the kind of cancer you have. PEGPH20 is an enzyme (protein that can speed biochemical reactions) that breaks down a specific substance called hyaluronan produced by some tumors. The removal of hyaluronan from tumors has been shown to inhibit tumor growth.

Atezolizumab is an immunotherapy drug which means it assists your immune system in fighting your cancer. This drug has been approved by the United States Food and Drug Administration (FDA) to treat bladder and lung cancer, but is investigational with the drugs described above and for the diagnosis of intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma . The other therapy that is given in this study is standard of care chemotherapy drugs Cisplatin and Gemcitabine, which are drugs that are routinely given to treat patients with cholangiocarcinoma or gallbladder adenocarcinoma cancers who are not in research studies.

The investigator in charge of this study at MUSC is Dr. Carolyn Britten. Approximately 70 subjects will take part study wide at about 20 centers in the United States and 10 centers in Asia. Halozyme will be providing funding to MUSC and Dr. Britten for conducting this research.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-4271
hcc-clinical-trials@musc.edu

An Open-label Phase 1/2A Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TRC253, an Androgen Receptor Antagonist, in Patients With Metastatic Castration-resistant Prostate Cancer Save

Date Added
September 26th, 2017
PRO Number
Pro00067101
Researcher
Michael Lilly

Silhouette
Keywords
Cancer/Genitourinary, Drug Studies
Summary

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The estimated completion date is September 2018.

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

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