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Comparing Nadofaragene Firadenovec to Observation for Bladder Cancer

A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

PHASE3 · Ferring Pharmaceuticals · NCT06510374

This study is testing if a new treatment for bladder cancer can help prevent it from coming back compared to just keeping an eye on it.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment454 (estimated)
Ages18 Years and up
SexAll
SponsorFerring Pharmaceuticals (industry)
Drugs / interventionschemotherapy
Locations97 sites (Mobile, Alabama and 96 other locations)
Trial IDNCT06510374 on ClinicalTrials.gov

What this trial studies

This phase 3b trial evaluates the efficacy of Nadofaragene Firadenovec compared to observation in patients diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC). Participants must have undergone a complete transurethral resection of bladder tumor (TURBT) within the last 60 days and meet specific criteria for their cancer type. The study aims to determine if the treatment can reduce recurrence rates compared to simply monitoring the condition. It is a randomized, controlled trial designed to provide robust data on the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with intermediate risk non-muscle invasive bladder cancer who have recently undergone TURBT.

Not a fit: Patients with muscle invasive or metastatic bladder cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of bladder cancer in patients with intermediate risk.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

    * 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 Criteria:

* 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
* Any prostatic urethral involvement

Low risk NMIBC defined as:

* 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

Where this trial is running

Mobile, Alabama and 96 other locations

+47 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.