KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC
Ashish M Kamat, Neal Shore, Noah Hahn, Shaheen Alanee, Hiroyuki Nishiyama, Shahrokh Shariat, Kijoeng Nam, Ekta Kapadia, Tara Frenkl, Gary Steinberg, Ashish M Kamat, Neal Shore, Noah Hahn, Shaheen Alanee, Hiroyuki Nishiyama, Shahrokh Shariat, Kijoeng Nam, Ekta Kapadia, Tara Frenkl, Gary Steinberg
Abstract
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.
Keywords: Bacillus Calmette-Guérin; bladder cancer; immunotherapy; nonmuscle-invasive bladder cancer; pembrolizumab; programmed death 1; programmed death ligand 1.
Source: PubMed