Fujieda Shizuoka, Japan

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

Cohort C(All Countries) : An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy. Cohort P(Japan and the United States Only): To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS. BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.