Comparing Nadofaragene Firadenovec to Observation for Bladder Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of South Alabama (USA) Health System - USACM
  Mobile, Alabama, United States Recruiting
• Urology Associates of Mobile
  Mobile, Alabama, United States Recruiting
• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• Center for Neurosciences
  Tucson, Arizona, United States Recruiting
• Arkansas Urology, North Little Rock
  Little Rock, Arkansas, United States Recruiting
• Michael G Oefelein, MD Clinical Trials
  Bakersfield, California, United States Recruiting

+66 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Ferring Pharmaceuticals
• Email: disclosure@ferring.com
• Phone: 833-548-1402

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.