Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

Who May Qualify: - Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020) - Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization: - Recurrence within 1 year, low-grade Ta - Solitary low-grade Ta \>3 cm - Low-grade Ta, multifocal - Solitary high-grade Ta, ≤3 cm - Low-grade T1 - Restage TURBT may be done at the discretion of the investigator Who Should NOT Join This Trial: - Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit High risk NMIBC defined as: - High-grade T1 - Any recurrent, high-grade Ta - High-grade Ta \>3 cm (or multifocal) - Any carcinoma in situ (CIS) - Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject - Any variant histology - Any prostatic urethral involvement Low risk NMIBC defined as: - First occurrence of low-grade solitary Ta ≤3 cm - Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence - Papillary urothelial neoplasm of low malignant potential Always talk to your doctor about whether this trial is right for you.