Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

NCT06510374 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: 000423U1111-1284-0685
• Study Type: interventional
• Target: 454
• Locations: 7 countries
• Sites: 82

Brief Summary

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Conditions

Intermediate Risk Non-Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence Free survival

  Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.

  24 months

Secondary Outcomes (3)

• Adverse Events

  up to 24 months

• Recurrence Free Survival at 12 Months

  12 months

• Recurrence Free Survival at 24 Months

  24 Months

Study Arms (2)

Arm 1 Nadofaragene Firadenovec

EXPERIMENTAL

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.

Drug: Nadofaragene Firadenovec

Arm 2 - Observation

NO INTERVENTION

Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. .

Interventions

Nadofaragene Firadenovec DRUG

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

Also known as: Adstiladrin

Arm 1 Nadofaragene Firadenovec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (82)

University of South Alabama (USA) Health System - USACM

Mobile, Alabama, 36606, United States

RECRUITING

Urology Associates of Mobile

Mobile, Alabama, 56608, United States

RECRUITING

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Urology Associates of Central California

Fresno, California, 93720, United States

RECRUITING

American Institute of Research

Los Angeles, California, 90017, United States

RECRUITING

Urology Center of Southern California

Murrieta, California, 92563, United States

RECRUITING

University of California, Irvine

Orange, California, 92868, United States

RECRUITING

Providence Saint John's Cancer Institute

Santa Monica, California, 90404, United States

RECRUITING

Advent Health

Denver, Colorado, 80210, United States

RECRUITING

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Advanced Urology institute - Pinellas

Largo, Florida, 33771, United States

RECRUITING

Sarasota Memorial Healthcare System

Sarasota, Florida, 34239, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

NextStage Clinical Research

Lisle, Illinois, 60532, United States

RECRUITING

Blessing Health System

Quincy, Illinois, 62301, United States

RECRUITING

Wichita Urology Group

Wichita, Kansas, 67226, United States

RECRUITING

University of Kentucky (UK) - Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Anne Arundel Urology, PA

Annapolis, Maryland, 21401, United States

RECRUITING

Mayo Clinic - Rochester Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Specialty Clinical Research of St. Louis

St Louis, Missouri, 63141, United States

RECRUITING

Adult and Pediatric Urology P.C.

Omaha, Nebraska, 68114, United States

RECRUITING

Atlantic Health

Morristown, New Jersey, 07960, United States

RECRUITING

Albany Medical College

Albany, New York, 10461, United States

RECRUITING

Great Lakes Physician PC d/b/a Western New York Urology Associates

Cheektowaga, New York, 14225, United States

RECRUITING

AccuMed Research Associates

Garden City, New York, 11530, United States

RECRUITING

Northwell Health -The Arthur Smith Institute for Urology

Lake Success, New York, 11042, United States

RECRUITING

Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center

New York, New York, 10010, United States

RECRUITING

Integrated Medical Professionals, PLLC

New York, New York, 10016, United States

RECRUITING

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Oregon Health and Science University (Portland)

Portland, Oregon, 97239, United States

RECRUITING

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

RECRUITING

Keystone Urology Specialists

Lancaster, Pennsylvania, 17601, United States

RECRUITING

University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology Austin

Austin, Texas, 78759, United States

RECRUITING

Urology Clinics of North Texas PLLC (Dallas)

Dallas, Texas, 75231, United States

RECRUITING

Houston Metro Urology - Memorial City

Houston, Texas, 77027, United States

RECRUITING

Houston Methodist Hospital (Houston)

Houston, Texas, 77030, United States

RECRUITING

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

RECRUITING

Prostate Cancer Centre

Calgary, Alberta, T2V1P9, Canada

RECRUITING

G kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, L7N 3V2, Canada

RECRUITING

Fakultní Thomayerova Nemocnice

Prague, Prague, 140 59, Czechia

RECRUITING

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

RECRUITING

CHU Toulouse - Hopital Rangueil

Toulouse, Haute-Garonne, 31059, France

RECRUITING

CHU Nantes - Hotel Dieu

Nantes, Nantes, 44093, France

RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, New Aquitaine, 33076, France

RECRUITING

CHU de Rouen - Hopital Charles-Nicolle

Rouen, Normandy, 76031, France

RECRUITING

Centre Hospitalier Universitaire De Nimes (Nîmes)

Nîmes, Occitanie, 30229, France

RECRUITING

Centre Hospitaliser Universitaire de Lyon Sud

Lyon, Rhone-Alpe, 69310, France

RECRUITING

Hospices Civils de Lyon - Edouard Herriot Hosp.

Lyon, Rhône-Alps, 69003, France

RECRUITING

Hopital La Pitie Salpetriere

Paris, 75013, France

RECRUITING

APHP - Hopital Bichat

Paris, Île-de-France Region, 75018, France

RECRUITING

Aichi Medical University Hospital

Nagakute, Aichi-ken, 480-1195, Japan

RECRUITING

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

RECRUITING

Japanese Red Cross Narita Hospital

Narita, Chiba, 286-8523, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

RECRUITING

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

RECRUITING

Hitachi General Hospital

Hitachi, Ibaraki, 317-0077, Japan

RECRUITING

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

RECRUITING

St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

Kochi Medical School Hospital

Nankoku, Kochi, 783-8505, Japan

RECRUITING

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

RECRUITING

Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan

RECRUITING

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, 113-8519, Japan

RECRUITING

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

RECRUITING

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, Seoul, 02841, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Córdoba, 14004, Spain

RECRUITING

Hospital Universitario de A Coruna

A Coruña, Galicia, 15006, Spain

RECRUITING

Hospital Universitario Virgen De Las Nieves

Granada, Granada, 18014, Spain

RECRUITING

Universidad Autonoma de Madrid. Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

RECRUITING

Hospital Universitario 12 De Octubre (Madrid)

Madrid, 28041, Spain

RECRUITING

Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)

Málaga, 29010, Spain

RECRUITING

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceutical

  STUDY DIRECTOR

Central Study Contacts

Ferring Pharmaceuticals

CONTACT

833-548-1402; disclosure@ferring.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); CA (2); JP (15); FR (10); KR (4); ES (9); US (41)