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)
Recruiting
99 years or below
All
Phase
3
1 Location
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: TBD
-
Age: 99 years or below
-
Gender: All
Updated on
13 Feb 2019.
Study ID: 832206
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