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Active, Not Recruiting

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

Updated: 15 August, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

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