Study Comparing Nadofaragene Firadenovec to Observation in Patients with Intermediate Risk Non-Muscle Invasive Bladder Cancer

Inclusion Criteria

• Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) according to specific medical guidelines.
• Have had a complete removal of bladder tumors through a procedure called transurethral resection of bladder tumor (TURBT) within the last 60 days, with or without chemotherapy given during surgery.
• Specific conditions include:
  • Tumor recurrence within 1 year, low-grade Ta
  • A single low-grade Ta tumor larger than 3 cm
  • Multiple low-grade Ta tumors
  • A single high-grade Ta tumor 3 cm or smaller
  • Low-grade T1 tumor
• A second TURBT may be done if the doctor thinks it's necessary.

Exclusion Criteria

• Evidence of muscle invasive or spread of cancer at the time of screening.
• High risk non-muscle invasive bladder cancer (NMIBC) defined as:
  • High-grade T1 tumor
  • Any recurring high-grade Ta tumor
  • High-grade Ta tumor larger than 3 cm or multiple tumors
  • Any carcinoma in situ (CIS)
  • Any failure of Bacillus Calmette-Guérin (BCG) treatment in high-grade cases
  • Any unusual cell types
  • Any involvement of the prostate area
• Low risk NMIBC defined as:
  • First occurrence of a single low-grade Ta tumor 3 cm or smaller
  • Recurrence of a single low-grade Ta tumor 3 cm or smaller more than 12 months after the previous occurrence
  • Papillary urothelial neoplasm of low malignant potential