Tests nadofaragene firadenovec against observation in bladder cancer
Compares nadofaragene firadenovec with observation in adults with intermediate-risk bladder cancer.
Plain-language title generated from the registry record
Registry title: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Key facts
- Where
- Albany, Annapolis, Atlanta, Austin, Bakersfield, Bala-Cynwyd, Boston, Cheektowaga, Cincinnati, Clive, Creve Coeur, Dallas, Denver, Fresno, Garden City, Germantown, Houston, Jacksonville, Jeffersonville, Lake Success, Lakeland, Lancaster, Largo, Lexington, Lisle, Little Rock, Los Angeles, Mobile, Morristown, Murrieta, Myrtle Beach, New York, Omaha, Orange, Philadelphia, Phoenix, Pittsburgh, Portland, Poughkeepsie, Quincy, Raleigh, Rochester, Santa Monica, Sarasota, Southaven, Spokane, St Louis, The Bronx, Tucson, Virginia Beach, Washington D.C., and Wichita, United StatesSee the 55 sites
- Phase
- Phase 3
Where in United States
- Albany Medical CollegeAlbany, United StatesTaking people
- Anne Arundel Urology, PAAnnapolis, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Urology AustinAustin, United StatesTaking people
- Michael G Oefelein, MD Clinical TrialsBakersfield, United StatesTaking people
- MidLantic UrologyBala-Cynwyd, United StatesTaking people
- Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)Boston, United StatesTaking people
- Great Lakes Physician PC d/b/a Western New York Urology AssociatesCheektowaga, United StatesTaking people
- University of CincinnatiCincinnati, United StatesTaking people
- Urology Center of Iowa ResearchClive, United StatesTaking people
- Mercy Clinic Oncology and Hematology - David C. Pratt Cancer CenterCreve Coeur, United StatesNo longer taking part
- Urology Clinics of North Texas PLLC (Dallas)Dallas, United StatesTaking people
- Advent HealthDenver, United StatesTaking people
- Urology Associates of Central CaliforniaFresno, United StatesTaking people
- AccuMed Research AssociatesGarden City, United StatesTaking people
- The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)Germantown, United StatesTaking people
- Houston Methodist Hospital (Houston)Houston, United StatesTaking people
- Houston Metro Urology - Memorial CityHouston, United StatesTaking people
- Mayo ClinicJacksonville, United StatesTaking people
- First Urology Research (Jeffersonville)Jeffersonville, United StatesTaking people
- Northwell Health -The Arthur Smith Institute for UrologyLake Success, United StatesTaking people
- Lakeland Regional Health North Campus - Hollis Cancer CenterLakeland, United StatesTaking people
- Keystone Urology SpecialistsLancaster, United StatesTaking people
- Advanced Urology institute - PinellasLargo, United StatesTaking people
- University of Kentucky (UK) - Markey Cancer CenterLexington, United StatesTaking people
- NextStage Clinical ResearchLisle, United StatesTaking people
- Arkansas Urology, North Little RockLittle Rock, United StatesTaking people
- American Institute of ResearchLos Angeles, United StatesTaking people
- University of South Alabama (USA) Health System - USACMMobile, United StatesTaking people
- Urology Associates of MobileMobile, United StatesTaking people
- Atlantic HealthMorristown, United StatesTaking people
- Urology Center of Southern CaliforniaMurrieta, United StatesTaking people
- Carolina Urologic Research CenterMyrtle Beach, United StatesTaking people
- Integrated Medical Professionals, PLLCNew York, United StatesTaking people
- Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical CenterNew York, United StatesTaking people
- Adult and Pediatric Urology P.C.Omaha, United StatesTaking people
- University of California IrvineOrange, United StatesTaking people
- University of Pennsylvania - Perelman Center for Advanced Medicine - Penn UrologyPhiladelphia, United StatesTaking people
- Mayo Clinic - ArizonaPhoenix, United StatesTaking people
- University of Pittsburgh Medical Center - Shadyside Medical BuildingPittsburgh, United StatesTaking people
- Oregon Health and Science University (Portland)Portland, United StatesTaking people
- Premier Medical Group of the Hudson ValleyPoughkeepsie, United StatesNo longer taking part
- Blessing Health SystemQuincy, United StatesTaking people
- WakemedRaleigh, United StatesTaking people
- Mayo Clinic - Rochester MinnesotaRochester, United StatesTaking people
- Providence Saint John's Cancer InstituteSanta Monica, United StatesTaking people
- Sarasota Memorial HealthCare SystemSarasota, United StatesTaking people
- The Urology Group P.CSouthaven, United StatesTaking people
- Spokane Urology PLLCSpokane, United StatesTaking people
- Specialty Clinical Research of St. LouisSt Louis, United StatesTaking people
- James J Peters VA Medical CenterThe Bronx, United StatesTaking people
- Center for NeurosciencesTucson, United StatesTaking people
- Urology of VirginiaVirginia Beach, United StatesTaking people
- MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
- Wichita Urology GroupWichita, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ferring Pharmaceuticals
- Trial code
- NCT06510374EU 2024-512029-10-00
- Record updated
- 30 October 2026
- Original description
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)Read full original descriptionShow less
A Phase 3b, Randomized, Controlled 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 (IR NMIBC)
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 risk NMIBC defined as:; Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence; Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject; Papillary urothelial neoplasm of low malignant potential; High-grade T1; Any recurrent, high-grade Ta; High-grade Ta >3 cm (or multifocal); Any carcinoma in situ (CIS); Any variant histology; Any prostatic urethral involvement; Low risk NMIBC defined as:; First occurrence of low-grade solitary Ta ≤3 cm.