A Phase 2 Multi-Arm, Multi Cohort, Open Label Study To Evaluate The Safety And Efficacy Of Cretostemogene Grenadenorepvec In Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
Objective
Primary: Arms 1 and 2: Determine the complete response (CR) rate at any time following treatment with cretostimogene in participants with BCG-naive CIS with or without concomitant HG Ta or T1 disease at baseline.
Arm 3: Determine the High-Grade Event-Free Survival (HG EFS) following treatment with cretostimogene in participants with BCG-naive HG Ta/T1 disease without concomitant CIS at baseline.
Secondary: Arms 1 and 2 only: Evaluate cretostimogene genome and granulocyte macrophage-colony stimulating factor (GM-CSF) levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation. Arms 1 and 2 only: Assess duration of response (DoR) Arms 1 and 2 only: Determine CR at 12 months Arm 3 only: Determine the HG EFS at 12 months - Evaluate all-cause event-free survival (EFS) - Evaluate progression-free survival (PFS) - Evaluate cystectomy-free survival - Assess bladder cancer-specific survival - Assess safety of cretostimogene
