A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Objective
Primary Objective: The primary objective of the study is to evaluate the RFS of TURBT followed by cretostimogene versus TURBT followed by observation in participants with IR-NMIBC.
Secondary Objectives: Evaluate the RFS at 12 months and 24 months. Assess progression free survival. Evaluate the frequency of radical cystectomy. Evaluate the time to next bladder cancer-related intervention. Evaluate the high-grade RFS. Evaluate the safety of cretostimogene treatment.
