Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Cohort A Key Inclusion Criteria:

• Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.

Participants with BCG-naïve NMIBC should have either:

• No prior treatment with BCG OR
• No treatment with BCG within the past 24 months prior to current pathological diagnosis OR
• A maximum of 1 or 2 doses of BCG within the past 24 months prior to current pathological diagnosis.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.
• Acceptable baseline organ function.

Cohort B Key Inclusion Criteria:

• Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.
• Acceptable baseline organ function.

Key Exclusion Criteria (Both Cohorts):

• Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
• High-grade disease in the upper urinary tract or prostatic urethra within 24 months of randomization or any history of muscle-invasive, locally advanced or metastatic disease in the upper urinary tract.
• Significant immunodeficiency.
• Pregnant or breastfeeding.