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Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Sponsor: Ferring Pharmaceuticals
Summary
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Official title: A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
454
Start Date
2024-10-01
Completion Date
2031-06-30
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Locations (79)
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
Providence Saint John's Cancer Institute
Santa Monica, 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
NextStage Clinical Research
Lisle, Illinois, 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
Anne Arundel Urology, PA
Annapolis, Maryland, 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
Centre Hospitaliser Universitaire de Lyon Sud
Lyon, Rhone-Alpe, 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
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Asan Medical Center
Seoul, Songpa-gu, 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
Universidad Autonoma de Madrid. Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario 12 De Octubre (Madrid)
Madrid, Spain
Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
Málaga, Spain