RecruitingIntermediate Risk Non-Muscle Invasive Bladder Cancer
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
29 states
Healthy volunteers
No
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About this study
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Sponsor: Ferring Pharmaceuticals
You may qualify 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.
You may not qualify 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06510374 · last updated 2026-09-25