NCT06510374From ClinicalTrials.govRecruiting

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

Intermediate Risk Non-Muscle Invasive Bladder Cancer

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Ferring Pharmaceuticals
Enrolment target: 454
Started: 1 October 2024
Main results due: 30 June 2028
Study sites: 110
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Study sites(110)

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
Urology Associates of Central California
Fresno, California, United States
Recruiting
American Institute of Research
Los Angeles, California, United States
Recruiting
Urology Center of Southern California
Murrieta, California, United States
Recruiting
University of California, Irvine
Orange, California, United States
Recruiting
Providence Saint John's Cancer Institute
Santa Monica, California, United States
Recruiting
Advent Health
Denver, Colorado, United States
Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
Mayo Clinic
Jacksonville, Florida, United States
Recruiting
Advanced Urology institute - Pinellas
Largo, Florida, United States
Recruiting
Sarasota Memorial Healthcare System
Sarasota, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
NextStage Clinical Research
Lisle, Illinois, United States
Recruiting
Blessing Health System
Quincy, Illinois, United States
Recruiting
First Urology Research (Jeffersonville)
Jeffersonville, Indiana, United States
Recruiting
Urology Center of Iowa Research
Clive, Iowa, United States
Recruiting
Wichita Urology Group
Wichita, Kansas, United States
Recruiting
University of Kentucky (UK) - Markey Cancer Center
Lexington, Kentucky, United States
Recruiting
Anne Arundel Urology, PA
Annapolis, Maryland, United States
Recruiting
Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Recruiting
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, United States
Recruiting
The Urology Group P.C
Southaven, Mississippi, United States
Recruiting
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
Creve Coeur, Missouri, United States
Terminated
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Recruiting
Adult and Pediatric Urology P.C.
Omaha, Nebraska, United States
Recruiting
Atlantic Health
Morristown, New Jersey, United States
Recruiting
Albany Medical College
Albany, New York, United States
Recruiting
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, United States
Recruiting
AccuMed Research Associates
Garden City, New York, United States
Recruiting
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States
Recruiting
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
New York, New York, United States
Recruiting
Integrated Medical Professionals, PLLC
New York, New York, United States
Recruiting
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Terminated
James J. Peters VA Medical Center
The Bronx, New York, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Oregon Health and Science University (Portland)
Portland, Oregon, United States
Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center - Shadyside Medical Building
Pittsburgh, Pennsylvania, United States
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Recruiting
The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)
Germantown, Tennessee, United States
Recruiting
Urology Austin
Austin, Texas, United States
Recruiting
Urology Clinics of North Texas PLLC (Dallas)
Dallas, Texas, United States
Recruiting
Houston Metro Urology - Memorial City
Houston, Texas, United States
Recruiting
Houston Methodist Hospital (Houston)
Houston, Texas, United States
Recruiting
Urology of Virginia
Virginia Beach, Virginia, United States
Recruiting
Spokane Urology PLLC
Spokane, Washington, United States
Recruiting
Prostate Cancer Centre
Calgary, Alberta, Canada
Recruiting
G kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada
Recruiting
Research St. Joseph's- Hamilton/St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Recruiting
University Health Network UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Fakultní Thomayerova Nemocnice
Prague, Prague, Czechia
Recruiting
Androgeos, spol. s r.o. Location
Prague, Prague, Czechia
Recruiting
Kromerizska Nemocnice A S
Kroměříž, Czechia
Recruiting

Showing 60 of 110 sites — filter to narrow it down. 108 of the 110 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06510374. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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