Brief Title: Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recurrence Free survival

Primary Outcome 1 - Timeframe: 24 months

CONDITION

• Intermediate Risk Non-Muscle Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Global Clinical Compliance

Role: Study Director

Affiliation: Ferring Pharmaceutical

Overall Contact

Name: Ferring Pharmaceuticals

Phone: 833-548-1402

Email: [email protected]

LOCATION