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
- Aarhus N, DenmarkSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with intermediate risk non-muscle invasive bladder cancer who recently had the tumor removed. It compares nadofaragene firadenovec with observation.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Intermediate risk non-muscle invasive bladder cancer (IR NMIBC), as defined by the AUA/SUO Guideline (2020). Examples: recurrence within 1 year of low-grade Ta, solitary low-grade Ta larger than 3 cm (1.2 in), multifocal low-grade Ta, solitary high-grade Ta of 3 cm (1.2 in) or less, or low-grade T1.
- Earlier treatment
- Must have had an adequate transurethral resection of bladder tumor (TURBT) within 60 days before randomization.
Main reasons for not taking part
- Current or previous muscle invasive or metastatic disease
- High risk NMIBC, such as high-grade T1, carcinoma in situ or any BCG failure in high-grade disease
- Low risk NMIBC, such as a first low-grade solitary Ta of 3 cm (1.2 in) or less
Read by machine on 10 November 2026.
Where in Denmark
- Region MidtjyllandAarhus N, DenmarkTaking 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.