RecruitingPhase 3NCT06510374

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

Sponsor

Ferring Pharmaceuticals

Enrollment

454 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Intermediate Risk Non-Muscle Invasive Bladder Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing an approved bladder cancer treatment — nadofaragene firadenovec (a gene therapy given into the bladder) — against active surveillance (watchful waiting) in patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC) after their tumor has been surgically removed. **You may be eligible if...** - You have been diagnosed with intermediate-risk non-muscle invasive bladder cancer as defined by standard urology guidelines - You have already had a procedure (TURBT) to remove the bladder tumor within the past 60 days - Your cancer fits one of the following: recurrent low-grade cancer, large solitary low-grade tumor, multiple low-grade tumors, small high-grade tumor (≤3 cm), or low-grade T1 cancer **You may NOT be eligible if...** - Your cancer is high-risk or has invaded the muscle layer of the bladder - You have certain other bladder conditions or previous bladder cancer treatments that disqualify you - You have severe urinary symptoms or significant other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNadofaragene Firadenovec

Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.

Locations(82)

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 Austin

Austin, Texas, United States

Urology Clinics of North Texas PLLC (Dallas)

Dallas, Texas, United States

Houston Metro Urology - Memorial City

Houston, 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

Fakultní Thomayerova Nemocnice

Prague, Prague, Czechia

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 Bordeaux - Hôpital Pellegrin

Bordeaux, New Aquitaine, France

CHU de Rouen - Hopital Charles-Nicolle

Rouen, Normandy, 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

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NCT06510374