Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Phase 1

Conditions: Metastatic Castration-Resistant Prostate Cancer
MedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2022-502909-15-00

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 477

Inclusion Criteria

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 Gonadotropinreleasing 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 Tcell 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., For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).