Gary D Steinberg, Neal D Shore, Joan Palou Redorta, Matthew D Galsky, Jens Bedke, Ja Hyeon Ku, Michal Kretkowski, Hailong Hu, Konstantin Penkov, Jennifer J Vermette, Jamal C Tarazi, Alison E Randall, Kristen J Pierce, Daniel Saltzstein, Thomas B Powles

CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer

  • Cancer Research
  • Oncology
  • General Medicine
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Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC. Eligible participants are randomized to receive sasanlimab plus BCG (induction ± maintenance) or BCG alone for up to 25 cycles within 12 weeks of TURBT. The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is around 1000 participants.

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