Clinical trial

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With…

NCT04149574 · Bristol-Myers Squibb, Industry · Terminated

Key facts

NCT number NCT04149574
Title 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
Acronym CheckMate 7G8
Lead sponsor Bristol-Myers Squibb, Industry
Status Terminated
Phase Phase 3
Study type Interventional
Conditions Urinary Bladder Neoplasms
Intervention type Biological, Drug, Other
Interventions nivolumab, Placebo, Bacillus Calmette-Guérin (BCG)
Enrollment 13
Start date Jan 15, 2020
Primary completion Oct 31, 2023
Completion Oct 31, 2023
First posted Nov 4, 2019
Last update posted Sep 16, 2025
Countries Argentina, Australia, Austria, Brazil, Canada, Chile, France, Germany, Greece, Israel, Italy, Netherlands and 4 more

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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