KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC.

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.

Future oncology (London, England). 2020 Mar 12 [Epub ahead of print]

Ashish M Kamat, Neal Shore, Noah Hahn, Shaheen Alanee, Hiroyuki Nishiyama, Shahrokh Shariat, Kijoeng Nam, Ekta Kapadia, Tara Frenkl, Gary Steinberg

Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA., Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA., Department of Oncology & Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA., Department of Urology, Henry Ford Hospital, Detroit, MI 48202, USA., Department of Urology, University of Tsukuba, Tsukuba 305-8577, Japan., Department of Urology, Medical University of Vienna, 1090 Vienna, Austria., Department of Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ 07033, USA., Department of Oncology, Merck & Co., Inc., Kenilworth, NJ 07033, USA., Department of Urology, NYU Langone Health, New York, NY 10017, USA.

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