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.
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
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.
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.
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.
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.
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.
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.
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.