Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
The purpose of this study is to find out the effectiveness of pembrolizumab in combination
with BCG as a first line therapy for participants with high grade T1 bladder cancer who are
at "high risk" for BCG alone to be ineffective and are seeking an alternative treatment
option to radical cystectomy. There is biologic rationale for combining pembrolizumab and BCG
as two distinct immunotherapies with possible additive or synergistic activity in urothelial
cancer. The combination of pembrolizumab with BCG will also be evaluated in an exploratory
cohort of patients with upper tract urothelial cancer.
Patients will receive pembrolizumab (MK-3475) administered after TUR in combination with BCG
as initial therapy. Pembrolizumab (MK-3475) will be administered as a 400 mg IV infusion at
6-week intervals (Q6W) for 9 doses over a 48 week period, unless there is unacceptable
toxicity or other reasons that would warrant the discontinuation of treatment. Patients will
receive once-weekly BCG therapy (TICE strain, 50 mg) for 6 consecutive weeks as a standard
induction course, given as intravesical BCG for patients with T1 bladder cancer, and
administered through a percutaneous nephrostomy tube in antegrade fashion for patients with
high-grade NMI-UTUC, consistent with standard clinical practice. BCG will start on week 3
after the first infusion of pembrolizumab (400 mg) to allow for initial priming of T cells to
further enhance the effects of BCG treatment. Initiation of induction BCG may be delayed (up
to 14 days) if deemed clinically indicated by the treating physician due to side effects from
TURBT or ureteroscopy and with permission from the Principal Investigator (PI).
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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