KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC
Future Oncology, 2020•Taylor & Francis
Background: Nonmuscle-invasive bladder cancer (NMIBC) is the most common form of
bladder cancer, with high rates of disease recurrence and progression. Current treatment for
high-risk NMIBC involves Bacillus Calmette-Guérin (BCG) therapy, but treatment options are
limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed
death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence
and progression, and pembrolizumab has shown efficacy in patients with BCG …
bladder cancer, with high rates of disease recurrence and progression. Current treatment for
high-risk NMIBC involves Bacillus Calmette-Guérin (BCG) therapy, but treatment options are
limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed
death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence
and progression, and pembrolizumab has shown efficacy in patients with BCG …
Background: Nonmuscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, with high rates of disease recurrence and progression. Current treatment for high-risk NMIBC involves Bacillus Calmette-Guérin (BCG) therapy, but treatment options are limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence and progression, and pembrolizumab has shown efficacy in patients with BCG-unresponsive high-risk NMIBC. Aim: To describe the rationale and design for the randomized, comparator-controlled Phase III KEYNOTE-676 study, which will evaluate the efficacy and safety of pembrolizumab in combination with BCG in patients with persistent/recurrent high-risk NMIBC after BCG induction therapy.
Trial registration number: NCT03711032
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