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

Prior treatment

• Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
  • High risk NMIBC defined as:
• Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence

Other illness

• Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
• Papillary urothelial neoplasm of low malignant potential

Other

• High-grade T1
• Any recurrent, high-grade Ta
• High-grade Ta \>3 cm (or multifocal)
• Any carcinoma in situ (CIS)
• Any variant histology
• Any prostatic urethral involvement
  • Low risk NMIBC defined as:
• First occurrence of low-grade solitary Ta ≤3 cm

• 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
  • Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
  • Restage TURBT may be done at the discretion of the investigator