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Active, Not Recruiting

A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650) - CA209-650

Updated: 5 January, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort A (Arm A)
Biological: Ipilimumab, Nivolumab
Experimental: Cohort B (Arm B)
Biological: Ipilimumab, Nivolumab
Experimental: Cohort C (Arm C)
Biological: Ipilimumab, Nivolumab
Experimental: Cohort D (Arm D1)
Biological: Nivolumab, Ipilimumab
Experimental: Cohort D (Arm D2)
Biological: Ipilimumab, Nivolumab
Experimental: Cohort D (Arm D3)
Biological: Ipilimumab
Experimental: Cohort D (Arm D4)
Drug: Prednisone, Cabazitaxel

Key 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

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