Tests nadofaragene firadenovec against observation in bladder cancer
Compares nadofaragene firadenovec with observation in adults with intermediate-risk bladder cancer.
Plain-language title generated from the registry record
Registry title: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Key facts
- Where
- Rome and Rozzano, ItalySee the 2 sites
- Phase
- Phase 3
Where in Italy
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ferring Pharmaceuticals
- Trial code
- NCT06510374EU 2024-512029-10-00
- Record updated
- 30 October 2026
- Original description
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)Read full original descriptionShow less
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Inclusion: 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: Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit; High risk NMIBC defined as:; Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence; Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject; Papillary urothelial neoplasm of low malignant potential; High-grade T1; Any recurrent, high-grade Ta; High-grade Ta >3 cm (or multifocal); Any carcinoma in situ (CIS); Any variant histology; Any prostatic urethral involvement; Low risk NMIBC defined as:; First occurrence of low-grade solitary Ta ≤3 cm.