Journal
FUTURE ONCOLOGY
Volume 16, Issue 10, Pages 507-516Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2019-0817
Keywords
Bacillus Calmette-Guerin; bladder cancer; immunotherapy; nonmuscle-invasive bladder cancer; pembrolizumab; programmed death 1; programmed death ligand 1
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Funding
- Merck Sharp Dohme Corp.
- FKD Industries
- Merck
- Sanofi
- Roche
- Astellas
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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-Guerin (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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