719TiP SunRISe-1: Phase IIb study of TAR-200 in combination with cetrelimab (CET), TAR-200 alone, or CET alone in participants with high risk non-muscle invasive bladder cancer unresponsive to intravesical bacillus Calmette-Guérin who are ineligible for or elected not to undergo radical cystectomy

Abstract

Treatment options are limited for patients (pts) with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) unresponsive to intravesical bacillus Calmette–Guérin (BCG). TAR-200 is an intravesical drug-delivery system which provides local continuous release of gemcitabine within the bladder. This study will assess rate of complete response (CR) upon treatment with TAR-200 + systemic CET (anti–PD-1 antibody), TAR-200, and CET in BCG-unresponsive pts with HR-NMIBC ineligible for or who decline radical cystectomy.