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Active, Not Recruiting

A Study to Evaluate Preliminary Safety and Efficacy of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer - CA209-650

Updated: 18 June, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants 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: Cytotoxic Chemotherapy
Biological: Ipilimumab Biological: Nivolumab
Experimental: Second Generation Hormone Therapies
Biological: Ipilimumab Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria) - 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) - Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment - Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before 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) Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us