A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
∙ Restage TURBT may be done at the discretion of the investigator
Locations
United States
Alabama
University of South Alabama (USA) Health System - USACM
RECRUITING
Mobile
Urology Associates of Mobile
RECRUITING
Mobile
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
California
Urology Associates of Central California
RECRUITING
Fresno
American Institute of Research
RECRUITING
Los Angeles
Urology Center of Southern California
RECRUITING
Murrieta
University of California, Irvine
RECRUITING
Orange
Providence Saint John's Cancer Institute
RECRUITING
Santa Monica
Colorado
Advent Health
RECRUITING
Denver
Washington, D.c.
Medstar Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
Mayo Clinic
RECRUITING
Jacksonville
Advanced Urology institute - Pinellas
RECRUITING
Largo
Sarasota Memorial Healthcare System
RECRUITING
Sarasota
Georgia
Emory University
RECRUITING
Atlanta
Illinois
NextStage Clinical Research
RECRUITING
Lisle
Blessing Health System
RECRUITING
Quincy
Kansas
Wichita Urology Group
RECRUITING
Wichita
Kentucky
University of Kentucky (UK) - Markey Cancer Center
RECRUITING
Lexington
Maryland
Anne Arundel Urology, PA
RECRUITING
Annapolis
Minnesota
Mayo Clinic - Rochester Minnesota
RECRUITING
Rochester
Missouri
Specialty Clinical Research of St. Louis
RECRUITING
St Louis
Nebraska
Adult and Pediatric Urology P.C.
RECRUITING
Omaha
New Jersey
Atlantic Health
RECRUITING
Morristown
New York
Albany Medical College
RECRUITING
Albany
Great Lakes Physician PC d/b/a Western New York Urology Associates
RECRUITING
Cheektowaga
AccuMed Research Associates
RECRUITING
Garden City
Northwell Health -The Arthur Smith Institute for Urology
RECRUITING
Lake Success
Integrated Medical Professionals, PLLC
RECRUITING
New York
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
RECRUITING
New York
James J. Peters VA Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Oregon
Oregon Health and Science University (Portland)
RECRUITING
Portland
Pennsylvania
MidLantic Urology
RECRUITING
Bala-cynwyd
Keystone Urology Specialists
RECRUITING
Lancaster
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
RECRUITING
Philadelphia
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Texas
Urology Clinics of North Texas PLLC (Dallas)
RECRUITING
Dallas
Houston Methodist Hospital (Houston)
RECRUITING
Houston
Virginia
Urology of Virginia
RECRUITING
Virginia Beach
Other Locations
Canada
G kenneth Jansz Medicine Professional Corporation
RECRUITING
Burlington
Prostate Cancer Centre
RECRUITING
Calgary
France
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU Clermont Ferrand - Hopital Gabriel Montpied
RECRUITING
Clermont-ferrand
Centre Hospitaliser Universitaire de Lyon Sud
RECRUITING
Lyon
Hospices Civils de Lyon - Edouard Herriot Hosp.
RECRUITING
Lyon
CHU Nantes - Hotel Dieu
RECRUITING
Nantes
Centre Hospitalier Universitaire De Nimes (Nîmes)
RECRUITING
Nîmes
APHP - Hopital Bichat
RECRUITING
Paris
Hopital La Pitie Salpetriere
RECRUITING
Paris
CHU de Rouen - Hopital Charles-Nicolle
RECRUITING
Rouen
CHU Toulouse - Hopital Rangueil
RECRUITING
Toulouse
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō-ku
Kyushu University Hospital
RECRUITING
Fukuoka
Hiroshima University Hospital
RECRUITING
Hiroshima
Hitachi General Hospital
RECRUITING
Hitachi
Nara Medical University Hospital
RECRUITING
Kashihara
St. Marianna University Hospital
RECRUITING
Kawasaki
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Aichi Medical University Hospital
RECRUITING
Nagakute
Nagoya University Hospital
RECRUITING
Nagoya
Kochi Medical School Hospital
RECRUITING
Nankoku
Japanese Red Cross Narita Hospital
RECRUITING
Narita
Mie University Hospital
RECRUITING
Tsu
University of Tsukuba Hospital
RECRUITING
Tsukuba
Wakayama Medical University Hospital
RECRUITING
Wakayama
Yokohama City University Hospital
RECRUITING
Yokohama
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Spain
Hospital Universitario de A Coruna
RECRUITING
A Coruña
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Basurto
RECRUITING
Bilbao
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario Virgen De Las Nieves
RECRUITING
Granada
Hospital Universitario 12 De Octubre (Madrid)
RECRUITING
Madrid
Universidad Autonoma de Madrid. Hospital Universitario La Paz
RECRUITING
Madrid
Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
RECRUITING
Málaga
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
RECRUITING
Santander
Contact Information
Primary
Ferring Pharmaceuticals
disclosure@ferring.com
833-548-1402
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 454
Treatments
Experimental: 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.
No_intervention: Arm 2 - Observation
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period.~.
Related Therapeutic Areas
Sponsors
Leads: Ferring Pharmaceuticals