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A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer - CA209-7DX

Updated: 31 January, 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 3


  • Gender(s)

  • 18+

    Age Range

  • 148


  • Recruiting

Treatment Options

Study Arms
Experimental: Arm A: (nivolumab + docetaxel + prednisone)
Biological: nivolumab Drug: docetaxel Drug: prednisone
Active Comparator: Arm B: (placebo + docetaxel + prednisone)
Drug: docetaxel Drug: prednisone

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic confirmation of adenocarcinoma of the prostate and evidence of stage IV disease - Must have ECOG performance status 0-1 - Documented prostate cancer progression per PCWG3 criteria within 6 months prior to screening - Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy - Participants who are chemotherapy-naive and received 1 to 2 prior second generation hormonal therapies - Sufficient tumor sample from fresh or archival tumor tissue obtained no more than 1 year prior to enrollment, from a metastatic lesion or primary tumor lesion that has not been previously irradiated Exclusion Criteria: - Participants with active brain metastases - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured - Participants with an active, known, or suspected autoimmune disease - Participants requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications - Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Prior treatment with docetaxel or another chemotherapy for metastatic castration resistant prostate cancer Other protocol defined inclusion/exclusion criteria could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com