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Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer - CA209-650

Updated: 15 October, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 53


  • Recruiting

Treatment Options

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

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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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