Merck BCG and Pembrolizumab for High-Risk Non-Muscle-Invasive Bladder Cancer
Lay Title:A Study for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Technical Title:A Phase 3 Trial of BCG with or without Pembrolizumab for High Risk Non-Muscle-Invasive Bladder Cancer (KEYNOTE-676)
Disease Type:Patients who have been treated with BCG and have recurrent or persistent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
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 will be randomized to receive BCG alone or BCG in combination with pembrolizumab. The study will be unblinded, so both you and your doctor will know what treatment you will get.
If you receive pembrolizumab, it will be given by an intravenous (IV) infusion about once every 3 weeks for 2 years. BCG will be given directly into your bladder through a catheter once a week for 6 weeks, then once a week for 3 weeks at Months 3, 6, 12, 18, 24, 30, and 36. 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):
Inclusion Criteria:
Exclusion Criteria:
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