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

Updated: 24 February, 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

  • 62


  • Recruiting

Treatment Options

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

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria) on previous bone, CT and/or MRI scan. - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - 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) - Participants with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment Exclusion Criteria: - Cancer that has spread to the liver or brain - Active, known, or suspected autoimmune disease or infection - Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) - Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment. Other protocol defined inclusion/exclusion criteria could apply

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Side Effects (Adverse Events) and other reportable events are defined here
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