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Nivolumab or Placebo combined with Docetaxel

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

  • Clinical Trial Information

    Trial Contact: Walton, Sherri; Manchola-Orozco, Carolina

    Trial Phone: 321.841.1907 ; 321.841.7293

  • IRB No: WIRB 20192343

    Protocol Abbrev: TRIO BMS CA209-7DX

    Principal Investigator: Julio J. Hajdenberg, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CA2097DX

    Treatment: Nivolumab or Placebo Combined with Docetaxel

    Therapies Involved: Oncology: 1st line

    ClinicalTrials.gov ID: NCT04100018

  • Objective

    The purpose of this study is to test the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation

  • Key Eligibility

    •  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