Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

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)

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