A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

Official Title

A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG


A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Trial Description

Primary Outcome:

  • Event Free Survival (EFS)
Secondary Outcome:
  • Worsening- Free Survival (WFS)
  • Overall Survival (OS)
  • Complete Response Rate (CRR)
  • Duration of Response (DOR)
  • Number of laboratory abnormalities
  • Number of Laboratory changes from baseline
  • Incidence of Adverse Events (AEs)
  • Incidence of serious adverse Events (SAEs)
  • Incidence of adverse events leading to discontinuation
  • Incidence of immune-medicated adverse events (IMAEs)
  • Incidence of Deaths

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society