Bladder Cancer Clinical Trial
Official title:
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)
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.
Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B). Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence. Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A. ;
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