Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
Trial Status: Active
The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior docetaxel-containing regimen.
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)
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
New York
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Pennsylvania
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
South Carolina
Charleston
Medical University of South Carolina
Status: ACTIVE
Texas
Houston
M D Anderson Cancer Center
Status: ACTIVE
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Bristol-Myers Squibb
- Primary ID CA209-650
- Secondary IDs NCI-2017-01488, 2016-001928-54
- Clinicaltrials.gov ID NCT02985957