A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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