A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Ferring Pharmaceuticals
Summary
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Restage TURBT may be done at the discretion of the investigator Exclu…
Interventions
- DrugNadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Locations (94)
- University of South Alabama (USA) Health System - USACMMobile, Alabama
- Urology Associates of MobileMobile, Alabama
- Mayo Clinic ArizonaPhoenix, Arizona
- Center for NeurosciencesTucson, Arizona
- Arkansas Urology, North Little RockLittle Rock, Arkansas
- Michael G Oefelein, MD Clinical TrialsBakersfield, California