A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Inclusion Criteria

• Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
• Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
• Solitary LG Ta >3 cm tumor
• Multifocal LG Ta tumors
• Primary and solitary HG Ta ≤3 cm tumor
• LG T1 tumor
• All visible disease removed by TURBT within 90 days of study randomization
• Acceptable baseline organ function

Exclusion Criteria

• High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)
• Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
• Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
• Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
• Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)