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 (43) 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
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
Florida
Advanced Urology institute - Pinellas
RECRUITING
Largo
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Blessing Health System
RECRUITING
Quincy
Kansas
Wichita Urology Group
RECRUITING
Wichita
Kentucky
University of Kentucky (UK) - Markey Cancer Center
RECRUITING
Lexington
Missouri
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
RECRUITING
Creve Coeur
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
Premier Medical Group of the Hudson Valley
RECRUITING
Poughkeepsie
James J. Peters VA Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Pennsylvania
MidLantic Urology
RECRUITING
Bala-cynwyd
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Texas
Houston Methodist Hospital (Houston)
RECRUITING
Houston
Virginia
Urology of Virginia
RECRUITING
Virginia Beach
Other Locations
Canada
G kenneth Jansz Medicine Professional Corporation
RECRUITING
Burlington
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
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