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
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Clinical Trial Information
Trial Contact: Walton, Sherri; Britton, David
Trial Phone: 321.841.1907 ; 321.841.2684
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IRB No: WIRB 20192343
Protocol Abbrev: TRIO BMS CA209-7DX
Principal Investigator:
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
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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
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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
