Gender
Male
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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
