Lay Title: Merck KEYNOTE-676: A Study for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Technical Title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is either Persistent or Recurrent Following BCG Induction or that is Naïve to BCG Treatment (KEYNOTE-676)
Disease Type: This study is for patients with high-risk non-muscle invasive bladder cancer (HR-NMIBC). Patients can enroll in one of two cohorts depending on their cancer treatment history. Cohort A is for patients who have been treated with BCG and have recurrent or persistent HR-NMIBC. Cohort B is for patients who have never received BCG for their bladder cancer, or have not received it within the past 2 years.
Basic information: The purpose of this research study is to test the safety of pembrolizumab in combination with Bacillus Calmette- Guerin (BCG) and to see how well this combination treatment works compared to BCG alone. Pembrolizumab (MK-3475) has been approved for patients with certain types of bladder cancer; however, it has not been approved for your type of bladder cancer. BCG has been approved for patients with your type of bladder cancer.
Research Procedures (not a complete list): Patients in Cohort A will be randomized to receive BCG alone or BCG in combination with pembrolizumab. BCG will be given weekly for the first 6 weeks, then once a week for 3 weeks at the end of months 3, 6, 12, 18, 24, 30, and 36. Pembrolizumab will be given once every 3 weeks for 2 years.
Patients in Cohort B will be randomized into one of three groups: (1) BCG (reduced maintenance) in combination with pembrolizumab; (2) BCG (full maintenance) in combination with pembrolizumab; and BCG only.
The study will be unblinded, so both you and your doctor will know what treatment you will get.
Pembrolizumab is given by an intravenous (IV) infusion. BCG is given directly into your bladder through a catheter. During study visits, you will undergo physical exams, cardiac tests, and blood and urine test. You will also undergo cystoscopies (examination to see the inside of your urinary bladder) and CT urograms (CT scan of your urinary tract) periodically.
Eligibility Criteria (not a complete list):
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