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Intermediate Risk Non-Muscle Invasive Bladder CancerPhase 3ABLE-32NCT06510374

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

A Phase 3 study testing Nadofaragene Firadenovec in people with Intermediate Risk Non-Muscle Invasive Bladder Cancer, run by Ferring Pharmaceuticals at 116 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Nadofaragene Firadenovec
Could I receive a placebo?
No, everyone receives an active treatment
How many people
454 participants
Where
116 sitesin 10 countries
Study dates
1 Oct 2024to 30 Sep 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

116 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Ferring Pharmaceuticals contact

833-548-1402

disclosure@ferring.com

116 sites in 10 countries

United States55 sites, 53 recruiting

  • Albany Medical College

    Albany, New York, 10461

    Recruiting

  • Anne Arundel Urology, PA

    Annapolis, Maryland, 21401

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Urology Austin

    Austin, Texas, 78759

    Recruiting

  • Michael G Oefelein, MD Clinical Trials

    Bakersfield, California, 93301

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02115

    Recruiting

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

    Cheektowaga, New York, 14225

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Recruiting

  • Urology Center of Iowa Research

    Clive, Iowa, 50325

    Recruiting

  • Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

    Creve Coeur, Missouri, 63141

    Terminated

  • Urology Clinics of North Texas PLLC (Dallas)

    Dallas, Texas, 75231

    Recruiting

  • Advent Health

    Denver, Colorado, 80210

    Recruiting

  • Urology Associates of Central California

    Fresno, California, 93720

    Recruiting

  • AccuMed Research Associates

    Garden City, New York, 11530

    Recruiting

  • The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)

    Germantown, Tennessee, 38138

    Recruiting

  • Houston Metro Urology - Memorial City

    Houston, Texas, 77027

    Recruiting

  • Houston Methodist Hospital (Houston)

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Recruiting

  • First Urology Research (Jeffersonville)

    Jeffersonville, Indiana, 47130

    Recruiting

  • Northwell Health -The Arthur Smith Institute for Urology

    Lake Success, New York, 11042

    Recruiting

  • Lakeland Regional Health North Campus - Hollis Cancer Center

    Lakeland, Florida, 33805

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17601

    Recruiting

  • Advanced Urology institute - Pinellas

    Largo, Florida, 33771

    Recruiting

  • University of Kentucky (UK) - Markey Cancer Center

    Lexington, Kentucky, 40536

    Recruiting

  • NextStage Clinical Research

    Lisle, Illinois, 60532

    Recruiting

  • Arkansas Urology, North Little Rock

    Little Rock, Arkansas, 72211

    Recruiting

  • American Institute of Research

    Los Angeles, California, 90017

    Recruiting

  • University of South Alabama (USA) Health System - USACM

    Mobile, Alabama, 36606

    Recruiting

  • Urology Associates of Mobile

    Mobile, Alabama, 56608

    Recruiting

  • Atlantic Health

    Morristown, New Jersey, 07960

    Recruiting

  • Urology Center of Southern California

    Murrieta, California, 92563

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

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

    New York, New York, 10010

    Recruiting

  • Integrated Medical Professionals, PLLC

    New York, New York, 10016

    Recruiting

  • Adult and Pediatric Urology P.C.

    Omaha, Nebraska, 68114

    Recruiting

  • University of California, Irvine

    Orange, California, 92868

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Recruiting

  • University of Pittsburgh Medical Center - Shadyside Medical Building

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Oregon Health and Science University (Portland)

    Portland, Oregon, 97239

    Recruiting

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12603

    Terminated

  • Blessing Health System

    Quincy, Illinois, 62301

    Recruiting

  • WakeMed

    Raleigh, North Carolina, 27610

    Recruiting

  • Mayo Clinic - Rochester Minnesota

    Rochester, Minnesota, 55905

    Recruiting

  • Providence Saint John's Cancer Institute

    Santa Monica, California, 90404

    Recruiting

  • Sarasota Memorial Healthcare System

    Sarasota, Florida, 34239

    Recruiting

  • The Urology Group P.C

    Southaven, Mississippi, 38654

    Recruiting

  • Spokane Urology PLLC

    Spokane, Washington, 99202

    Recruiting

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

    Recruiting

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468

    Recruiting

  • Center for Neurosciences

    Tucson, Arizona, 85718

    Recruiting

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

    Recruiting

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Recruiting

  • Wichita Urology Group

    Wichita, Kansas, 67226

    Recruiting

Other trials in United States

Japan17 sites, 17 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8519

    Recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

    Recruiting

  • Hitachi General Hospital

    Hitachi, Ibaraki, 317-0077

    Recruiting

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

    Recruiting

  • St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511

    Recruiting

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Recruiting

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

    Recruiting

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505

    Recruiting

  • Japanese Red Cross Narita Hospital

    Narita, Chiba, 286-8523

    Recruiting

  • The University of Tokyo Hospital

    Tokyo, Kanto, 113-8655

    Recruiting

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

    Recruiting

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

    Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

    Recruiting

Other trials in Japan

Spain11 sites, 11 recruiting

  • Hospital Universitario de A Coruna

    A Coruña, Galicia, 15006

    Recruiting

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

    Recruiting

  • Hospital del Mar

    Barcelona, Catalonia, 08003

    Recruiting

  • Hospital Universitario Basurto

    Bilbao, Vizcaya, 48013

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

    Recruiting

  • Hospital Universitario Virgen De Las Nieves

    Granada, Granada, 18014

    Recruiting

  • Universidad Autonoma de Madrid. Hospital Universitario La Paz

    Madrid, Madrid, 28046

    Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Recruiting

  • Hospital Universitario 12 De Octubre (Madrid)

    Madrid, 28041

    Recruiting

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

    Málaga, 29010

    Recruiting

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

    Santander, Cantabria, 39008

    Recruiting

Other trials in Spain

France10 sites, 10 recruiting

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, New Aquitaine, 33076

    Recruiting

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000

    Recruiting

  • Centre Hospitaliser Universitaire de Lyon Sud

    Lyon, Rhone-Alpe, 69310

    Recruiting

  • Hospices Civils de Lyon - Edouard Herriot Hosp.

    Lyon, Rhône-Alps, 69003

    Recruiting

  • CHU Nantes - Hotel Dieu

    Nantes, Nantes, 44093

    Recruiting

  • Centre Hospitalier Universitaire De Nimes (Nîmes)

    Nîmes, Occitanie, 30229

    Recruiting

  • Hopital La Pitie Salpetriere

    Paris, 75013

    Recruiting

  • APHP - Hopital Bichat

    Paris, Île-de-France Region, 75018

    Recruiting

  • CHU de Rouen - Hopital Charles-Nicolle

    Rouen, Normandy, 76031

    Recruiting

  • CHU Toulouse - Hopital Rangueil

    Toulouse, Haute-Garonne, 31059

    Recruiting

Other trials in France

South Korea8 sites, 8 recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Recruiting

  • Chonnam National University Hwasun Hospital (CNUHH)

    Hwasun, Jeollanam-do, 58128

    Recruiting

  • Korea University Anam Hospital

    Seoul, Seoul, 02841

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul, 06351

    Recruiting

  • Seoul National University Hospital

    Seoul, Songpa-gu, 03080

    Recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

    Recruiting

Other trials in South Korea

Czechia5 sites, 5 recruiting

  • Kromerizska Nemocnice A S

    Kroměříž, 76701

    Recruiting

  • Krajska Nemocnice Liberec

    Liberec, 46300

    Recruiting

  • Fakultní Thomayerova Nemocnice

    Prague, Prague, 140 59

    Recruiting

  • Androgeos, spol. s r.o. Location

    Prague, Prague, 160 00

    Recruiting

  • Fakultní Thomayerova Nemocnice

    Prague, 140 59

    Recruiting

Other trials in Czechia

Canada4 sites, 4 recruiting

  • G kenneth Jansz Medicine Professional Corporation

    Burlington, Ontario, L7N 3V2

    Recruiting

  • Prostate Cancer Centre

    Calgary, Alberta, T2V1P9

    Recruiting

  • Research St. Joseph's- Hamilton/St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

    Recruiting

  • University Health Network UHN - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

    Recruiting

Other trials in Canada

Poland3 sites, 3 recruiting

  • IN-VIVO Bydgoszcz

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048

    Recruiting

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.

    Poznan, Wielkopolska, 61-731

    Recruiting

  • Medical Concierge Centrum Medyczne

    Warsaw, Woj. Mazowieckie, 02-798

    Recruiting

Other trials in Poland

Italy2 sites, 2 recruiting

  • Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)

    Rome, Lazio, 00144

    Recruiting

  • Gruppo Humanitas - Humanitas Research Hospital (Instituto Clinico Humanitas)

    Rozzano, Lombardy, 20089

    Recruiting

Other trials in Italy

Denmark1 site, 1 recruiting

  • Aarhus University Hospital

    Aarhus, 8200

    Recruiting

Other trials in Denmark

About this study

Official title: 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)

Being tested
Nadofaragene Firadenovec

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nadofaragene FiradenovecDrug

    Also called Adstiladrin

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

Study groups in NCT06510374
Study groupRoleWhat they receive
Arm 1 Nadofaragene FiradenovecExperimentalParticipants 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.
Receives: Drug: Nadofaragene Firadenovec
Arm 2 - ObservationNo interventionSubjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. .

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (3)

  1. 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

    Measured: up to 24 months

  2. 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

    Measured: 12 months

  3. 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

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Oct 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510374
Sponsor's protocol ID
000423
Other IDs
U1111-1284-0685
Acronym
ABLE-32
Status last verified
Oct 2026
First submitted
15 Jul 2024
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nadofaragene Firadenovec in people with Intermediate Risk Non-Muscle Invasive Bladder Cancer, run by Ferring Pharmaceuticals at 116 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Japan, Spain, France, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ferring Pharmaceuticals (833-548-1402, disclosure@ferring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06510374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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