Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment

Inclusion Criteria: Cohorts A and B * High-grade (HG) NMIBC (HG Ta, CIS, and/or T1) of urothelial histology that is unresponsive to adequate BCG therapy. * Stage, grade, and histology must be confirmed by the MSK Department of Pathology * Subjects with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded * In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy/TURBT * In this context, adequate BCG therapy is defined as at least one of the following: * At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy * At least five of six doses of an initial induction course plus at least two of six doses of a second induction course * Disease unresponsive to adequate BCG therapy is defined as the following. Suspected recurrence from suspicious cytology or cystoscopy, and later confirmed via TURBT, is acceptable: * Persistent or recurrent CIS alone or with recurrent Ta/T1 disease (noninvasive papillary disease/tumor invades the subepithelial connective tissue) within 12 months of completion of adequate BCG therapy * Recurrent HG Ta/T1 disease within 6 months of completion of adequate BCG therapy * HG T1 disease at the first evaluation following an induction BCG course Cohort C: * Muslce invasive bladder cancer cT2-T4aN0-2 th…