Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (ABLE-32)

A Phase 3b, Randomized, Controlled 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 (IR NMIBC)

Study Overview

• Status: Recruiting
• Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer
• Intervention / Treatment: Drug: Nadofaragene Firadenovec

• Study Type: Interventional
• Enrollment (Estimated): 454
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ferring Pharmaceuticals; Phone Number: 833-548-1402; Email: disclosure@ferring.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V1P9
      • Recruiting
      • Prostate Cancer Centre
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • Recruiting
      • G kenneth Jansz Medicine Professional Corporation
    • Toronto, Ontario, Canada, M5G 1Z5
      • Recruiting
      • University Health Network UHN - Princess Margaret Cancer Centre
• Czechia
  • Liberec, Czechia, 46300
    • Recruiting
    • Krajská nemocnice Liberec
  • Prague, Czechia, 140 59
    • Recruiting
    • Fakultni Thomayerova nemocnice
  • Prague
    • Prague, Prague, Czechia, 140 59
      • Recruiting
      • Fakultni Thomayerova nemocnice
    • Prague, Prague, Czechia, 160 00
      • Recruiting
      • Androgeos, spol. s r.o. Location
• France
  • Paris, France, 75013
    • Recruiting
    • Hôpital La Pitié Salpêtrière
  • Auvergne-Rhône-Alpes
    • Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
      • Recruiting
      • CHU Clermont Ferrand - Hopital Gabriel Montpied
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Recruiting
      • CHU Toulouse - Hôpital Rangueil
  • Nantes
    • Nantes, Nantes, France, 44093
      • Recruiting
      • CHU NANTES - Hôtel Dieu
  • New Aquitaine
    • Bordeaux, New Aquitaine, France, 33076
      • Recruiting
      • CHU de Bordeaux - Hôpital Pellegrin
  • Normandy
    • Rouen, Normandy, France, 76031
      • Recruiting
      • CHU de Rouen - Hopital Charles-Nicolle
  • Occitanie
    • Nîmes, Occitanie, France, 30229
      • Recruiting
      • Centre Hospitalier Universitaire De Nimes (Nîmes)
  • Rhone-Alpe
    • Lyon, Rhone-Alpe, France, 69310
      • Recruiting
      • Centre Hospitaliser Universitaire de Lyon Sud
  • Rhône-Alps
    • Lyon, Rhône-Alps, France, 69003
      • Recruiting
      • Hospices Civils de Lyon - Edouard Herriot Hosp.
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75018
      • Recruiting
      • APHP - Hopital Bichat
• Japan
  • Aichi-ken
    • Nagakute, Aichi-ken, Japan, 480-1195
      • Recruiting
      • Aichi Medical University Hospital
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Recruiting
      • Nagoya University Hospital
  • Chiba
    • Narita, Chiba, Japan, 286-8523
      • Recruiting
      • Japanese Red Cross Narita Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 812-8582
      • Recruiting
      • Kyushu University Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 734-8551
      • Recruiting
      • Hiroshima University Hospital
  • Ibaraki
    • Hitachi, Ibaraki, Japan, 317-0077
      • Recruiting
      • Hitachi General Hospital
    • Tsukuba, Ibaraki, Japan, 305-8576
      • Recruiting
      • University of Tsukuba Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • Recruiting
      • St. Marianna University Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Recruiting
      • Yokohama City University Hospital
  • Kochi
    • Nankoku, Kochi, Japan, 783-8505
      • Recruiting
      • Kochi Medical School Hospital
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Recruiting
      • Mie University Hospital
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Recruiting
      • Nara Medical University Hospital
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8519
      • Recruiting
      • Institute of Science Tokyo Hospital
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Recruiting
      • Wakayama Medical University Hospital
• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 61-731
      • Recruiting
      • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
  • Woj. Mazowieckie
    • Warsaw, Woj. Mazowieckie, Poland, 02-798
      • Recruiting
      • Medical Concierge Centrum Medyczne
• South Korea
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10408
      • Recruiting
      • National Cancer Center
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, South Korea, 50612
      • Recruiting
      • Pusan National University Yangsan Hospital
  • Seoul
    • Seoul, Seoul, South Korea, 02841
      • Recruiting
      • Korea University Anam Hospital
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
  • Songpa-gu
    • Seoul, Songpa-gu, South Korea, 05505
      • Recruiting
      • Asan Medical Center
    • Seoul, Songpa-gu, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre (Madrid)
  • Málaga, Spain, 29010
    • Recruiting
    • Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
  • Catalonia
    • Barcelona, Catalonia, Spain, 08003
      • Recruiting
      • Hospital del Mar
  • Córdoba
    • Córdoba, Córdoba, Spain, 14004
      • Recruiting
      • Hospital Universitario Reina Sofia
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Recruiting
      • Hospital Universitario de A Coruña
  • Granada
    • Granada, Granada, Spain, 18014
      • Recruiting
      • Hospital Universitario Virgen de Las Nieves
  • Madrid
    • Madrid, Madrid, Spain, 28046
      • Recruiting
      • Universidad Autonoma de Madrid. Hospital Universitario La Paz
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Recruiting
      • Hospital Universitario Basurto
• United States
  • Alabama
    • Mobile, Alabama, United States, 36606
      • Recruiting
      • University of South Alabama (USA) Health System - USACM
    • Mobile, Alabama, United States, 56608
      • Recruiting
      • Urology Associates of Mobile
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States, 85718
      • Recruiting
      • Center for Neurosciences
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Urology, North Little Rock
  • California
    • Bakersfield, California, United States, 93301
      • Recruiting
      • Michael G Oefelein, MD Clinical Trials
    • Fresno, California, United States, 93720
      • Recruiting
      • Urology Associates of Central California
    • Los Angeles, California, United States, 90017
      • Recruiting
      • American Institute of Research
    • Murrieta, California, United States, 92563
      • Recruiting
      • Urology Center of Southern California
    • Orange, California, United States, 92868
      • Recruiting
      • University of California, Irvine
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Providence Saint John's Cancer Institute
  • Colorado
    • Denver, Colorado, United States, 80210
      • Recruiting
      • Advent Health
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
    • Largo, Florida, United States, 33771
      • Recruiting
      • Advanced Urology institute - Pinellas
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Healthcare System
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
  • Illinois
    • Lisle, Illinois, United States, 60532
      • Recruiting
      • NextStage Clinical Research
    • Quincy, Illinois, United States, 62301
      • Recruiting
      • Blessing Health System
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Recruiting
      • First Urology Research (Jeffersonville)
  • Iowa
    • Clive, Iowa, United States, 50325
      • Recruiting
      • Urology Center of Iowa Research
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Recruiting
      • Wichita Urology Group
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky (UK) - Markey Cancer Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Recruiting
      • Anne Arundel Urology, PA
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic - Rochester Minnesota
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Terminated
      • Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Specialty Clinical Research of St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Adult and Pediatric Urology P.C.
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Health
  • New York
    • Albany, New York, United States, 10461
      • Recruiting
      • Albany Medical College
    • Cheektowaga, New York, United States, 14225
      • Recruiting
      • Great Lakes Physician PC d/b/a Western New York Urology Associates
    • Garden City, New York, United States, 11530
      • Recruiting
      • AccuMed Research Associates
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health -The Arthur Smith Institute for Urology
    • New York, New York, United States, 10010
      • Recruiting
      • Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
    • New York, New York, United States, 10016
      • Recruiting
      • Integrated Medical Professionals, PLLC
    • Poughkeepsie, New York, United States, 12603
      • Terminated
      • Premier Medical Group of the Hudson Valley
    • The Bronx, New York, United States, 10468
      • Recruiting
      • James J. Peters VA Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University (Portland)
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • MidLantic Urology
    • Lancaster, Pennsylvania, United States, 17601
      • Recruiting
      • Keystone Urology Specialists
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center - Shadyside Medical Building
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Recruiting
      • Urology Austin
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Urology Clinics of North Texas PLLC (Dallas)
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital (Houston)
    • Houston, Texas, United States, 77027
      • Recruiting
      • Houston Metro Urology - Memorial City
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Recruiting
      • Urology of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

    • Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
    • Restage TURBT may be done at the discretion of the investigator

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Nadofaragene Firadenovec; Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.; Other Names: Adstiladrin
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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24	up to 24 months
Recurrence Free Survival at 12 Months	Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months	12 months
Recurrence Free Survival at 24 Months	Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months	24 Months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: 000423; U1111-1284-0685 (Other Identifier: World Health Organization (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No