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Trial of Nadofaragene Firadenovec for Intermediate Risk Non-Muscle Invasive Bladder Cancer

This study is testing a gene therapy called Nadofaragene Firadenovec against observation (watching closely) for people with intermediate risk non-muscle invasive bladder cancer (IR NMIBC). Nadofaragene Firadenovec works by boosting your body's natural interferon (IFN) alfa-2b to fight cancer. The goal is to see if Nadofaragene Firadenovec can help people stay cancer-free longer. To join, you must be at least 18 years old, have IR NMIBC, and have recently had surgery to remove bladder tumors. The study is currently recruiting about 454 participants, but its overall status is unclear.

Study design
This is a Phase 3b, randomized, controlled study comparing Nadofaragene Firadenovec to observation. It plans to enroll 454 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is to measure how long participants remain cancer-free, which will be checked at 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06510374

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Ferring Pharmaceuticals
~454 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:Nadofaragene Firadenovec

At a glance

Recruiting sites
105 of 107 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence Free survival
Measured over 24 months

Conditions

Intermediate Risk Non-Muscle Invasive Bladder Cancer

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT06510374

Where you'd take part

This study runs at 107 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aarhus University Hospital

    Aarhus, Denmarkno site contact published

    Recruiting

  • AccuMed Research Associates

    Garden City, New Yorkno site contact published

    Recruiting

  • Adult and Pediatric Urology P.C.

    Omaha, Nebraskano site contact published

    Recruiting

  • Advanced Urology institute - Pinellas

    Largo, Floridano site contact published

    Recruiting

  • Advent Health

    Denver, Coloradono site contact published

    Recruiting

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, Japanno site contact published

    Recruiting

  • Albany Medical College

    Albany, New Yorkno site contact published

    Recruiting

  • American Institute of Research

    Los Angeles, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Global Clinical Compliance · STUDY_DIRECTOR · Ferring Pharmaceutical

Who to contact

Ferring Pharmaceuticals
[email protected]
833-548-1402
Email the study team

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Eligibility criteria

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-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
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

What this trial measures

  • Recurrence Free survival24 months

    Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.