Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
NCT ID: NCT06510374
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
454 participants
INTERVENTIONAL
2024-10-01
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 Nadofaragene Firadenovec
Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits.
Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Arm 2 - Observation
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period.
.
No interventions assigned to this group
Interventions
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Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Restage TURBT may be done at the discretion of the investigator
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceutical
Locations
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University of South Alabama (USA) Health System - USACM
Mobile, Alabama, United States
Urology Associates of Mobile
Mobile, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Urology Associates of Central California
Fresno, California, United States
American Institute of Research
Los Angeles, California, United States
Urology Center of Southern California
Murrieta, California, United States
University of California, Irvine
Orange, California, United States
Advent Health
Denver, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Advanced Urology institute - Pinellas
Largo, Florida, United States
Sarasota Memorial Healthcare System
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Blessing Health System
Quincy, Illinois, United States
Wichita Urology Group
Wichita, Kansas, United States
University of Kentucky (UK) - Markey Cancer Center
Lexington, Kentucky, United States
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Adult and Pediatric Urology P.C.
Omaha, Nebraska, United States
Atlantic Health
Morristown, New Jersey, United States
Albany Medical College
Albany, New York, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
New York, New York, United States
Integrated Medical Professionals, PLLC
New York, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Science University (Portland)
Portland, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas PLLC (Dallas)
Dallas, Texas, United States
Houston Methodist Hospital (Houston)
Houston, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Prostate Cancer Centre
Calgary, Alberta, Canada
G kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
CHU Toulouse - Hopital Rangueil
Toulouse, Haute-Garonne, France
CHU Nantes - Hotel Dieu
Nantes, Nantes, France
CHU de Rouen - Hopital Charles-Nicolle
Rouen, Normandy, France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, Nouvelle-Aquitaine, France
Centre Hospitalier Universitaire De Nimes (Nîmes)
Nîmes, Occitanie, France
Hospices Civils de Lyon - Edouard Herriot Hosp.
Lyon, Rhône-Alps, France
Hopital La Pitie Salpetriere
Paris, , France
APHP - Hopital Bichat
Paris, Île-de-France Region, France
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hitachi General Hospital
Hitachi, Ibaraki, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Samsung Medical Center
Seoul, Seoul, South Korea
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Hospital Universitario de A Coruna
A Coruña, Galicia, Spain
Hospital Universitario Virgen De Las Nieves
Granada, Granada, Spain
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario 12 De Octubre (Madrid)
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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U1111-1284-0685
Identifier Type: OTHER
Identifier Source: secondary_id
000423
Identifier Type: -
Identifier Source: org_study_id
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