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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• University of South Alabama (USA) Health System - USACM, Mobile, Alabama, United States
• Urology Associates of Mobile, Mobile, Alabama, United States
• Mayo Clinic Arizona, Phoenix, Arizona, United States
• Center for Neurosciences, Tucson, Arizona, United States
• Arkansas Urology, North Little Rock, Little Rock, Arkansas, United States
• Michael G Oefelein, MD Clinical Trials, Bakersfield, California, United States
• Urology Associates of Central California, Fresno, California, United States
• American Institute of Research, Los Angeles, California, United States
• Urology Center of Southern California, Murrieta, California, United States
• University of California, Irvine, Orange, California, United States
• Providence Saint John's Cancer Institute, Santa Monica, California, United States
• Advent Health, Denver, Colorado, United States

+ 90 more sites.

Who to contact

Ferring Pharmaceuticals · 833-548-1402 · disclosure@ferring.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06510374.