A Phase 3 Randomized Comparator-Controlled Clinical Trial to Study the Efficacy of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) that is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

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Updated on 19 February 2024

Summary

This study will involve patients with high risk non-muscle invasive bladder cancer (NMIBC) that is persistent (cancer stays) or recurrent (cancer comes back) following Bacillus Calmette-Guérin BCG treatment. The purpose of this study is to: o Test the safety of the study drugs, pembrolizumab in combination with Bacillus Calmette-Guerin (BCG) o See how your body handles pembrolizumab and BCG o See how well pembrolizumab in combination with BCG works compared to BCG alone o See if pembrolizumab helps patients getting BCG have a better quality of life o See if pembrolizumab helps patients getting BCG live longer Pembrolizumab has been approved FDA-approved for use for patients with certain types of bladder cancer; however, it has not yet been approved for your type of bladder cancer. Therefore, for your type of bladder cancer it is considered experimental. BCG is a live, but weakened, bacterial preparation that has been FDA-approved for use approved for patients with your type of bladder cancer.

Details
Condition TBD
Age 99years or below
Clinical Study Identifier03711032
Last Modified on19 February 2024

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