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

Research output: Contribution to journalReview articlepeer-review

7 Scopus citations


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. 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: NCT0371103.

Original languageEnglish (US)
Pages (from-to)507-516
Number of pages10
JournalFuture Oncology
Issue number10
StatePublished - Apr 2020


  • Bacillus Calmette-Guérin
  • bladder cancer
  • immunotherapy
  • nonmuscle-invasive bladder cancer
  • pembrolizumab
  • programmed death 1
  • programmed death ligand 1

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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