A Study for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

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:

• Diagnosis of non-muscle invasive bladder cancer
• Prior treatment with only one induction course of BCG, with at least 5 BCG instillations within a 10-week period, with persistent or recurrent NMIBC. Note, patients who received more than one induction course or any maintenance course of BCG is not eligible.
• Willing to provide tissue for research purposes.

Exclusion Criteria:

• Muscle invasive, locally advanced non-resectable, or metastatic bladder cancer
• Urothelial carcinoma outside of the bladder (such as urethra, ureter, renal pelvis)
• Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, and other similar therapies

For More Detailed Information, Contact:

• Karim Chamie, MD, Principal Investigator, Associate Professor-in-Residence of UCLA Urology
• Ankush Sachdeva, Study Coordinator, (310) 794-3421