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

Official Title

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

Summary:

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

Trial Description

Primary Outcome:

  • Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR) per PCWG3
  • Time to Response per PCWG3 (TTR-PCWG3) determined by BICR
  • Duration of Response (DOR) per PCWG3 determined by BICR
  • Prostate-specific antigen (PSA) Response Rate (PSA-RR)
  • Time to PSA Progression (TTP-PSA)
  • Incidence of Adverse Events (AEs)
  • Incidence of Serious Adverse Events (SAEs)
  • Incidence of AEs leading to discontinuation
  • Incidence of immune-mediated AEs
  • Incidence of deaths
  • Incidence of laboratory abnormalities: Clinical Chemistry Tests
  • Incidence of laboratory abnormalities: Hematology tests
  • Incidence of laboratory abnormalities: Serology tests
  • Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF)
  • Incidence of changes from baseline in Physical Exam
  • Incidence of changes from baseline in vital signs: Respiratory rate
  • Incidence of changes from baseline in vital signs: Body temperature
  • Incidence of changes from baseline in vital signs: Blood pressure
  • Incidence of changes from baseline in vital signs: Heart Rate
  • Incidence of changes from baseline electrocardiogram (ECG)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society