Prostate Cancer Clinical Trial
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)
For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
Exclusion Criteria:
Presence of visceral metastases in the liver
Active brain metastases or leptomeningeal metastases
Active, known, or suspected autoimmune disease or infection
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)
Other protocol-defined inclusion/exclusion criteria apply
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 60 Locations for this study
Tucson Arizona, 85711, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Minneapolis Minnesota, 55404, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89169, United States
Albany New York, 12208, United States
Lake Success New York, 11042, United States
New York New York, 10029, United States
Tigard Oregon, 97223, United States
Allentown Pennsylvania, 18105, United States
Philadelphia Pennsylvania, 19104, United States
Charleston South Carolina, 29425, United States
Austin Texas, 78731, United States
Houston Texas, 77030, United States
Gosford New South Wales, 2250, Australia
Wahroonga New South Wales, 2076, Australia
Westmead New South Wales, 2145, Australia
Southport Queensland, 4215, Australia
Woolloongabba Queensland, 4012, Australia
Elizabeth Vale South Australia, 5112, Australia
Clayton Victoria, 3168, Australia
Wien , 1090, Austria
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2X 0, Canada
Aalborg , 9000, Denmark
Aarhus N , 8200, Denmark
Kobenhavn O , 2100, Denmark
Odense , 5000, Denmark
Clermont-ferrand , 63000, France
Lyon , 69008, France
Marseille Cedex 9 , 13273, France
Villejuif , 94805, France
Braunschweig , 38114, Germany
Dresden , 01307, Germany
Goettingen , 37075, Germany
Herne , 44625, Germany
Jena , 07747, Germany
Muenster , 48149, Germany
Munich , 81377, Germany
Nuernberg , 90419, Germany
Nuertingen , 72622, Germany
Rostock , 18107, Germany
Tuebingen , 72076, Germany
Wesel , 46483, Germany
Arezzo , 52100, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Parma , 43100, Italy
Terni , 05100, Italy
Kraków Małopolskie, 30-68, Poland
Koszalin , 75-58, Poland
Warszawa , 02-78, Poland
Badajoz , 06080, Spain
Barcelona , 08003, Spain
Madrid , 28007, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Santiago Compostela , 15706, Spain
How clear is this clinincal trial information?