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 114 sites in 10 countries.
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
- Conditions the study is for
- Intermediate Risk Non-Muscle Invasive Bladder Cancer
- What is being tested?
- Nadofaragene Firadenovec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 114 sitesin 10 countries
- Study dates
- 1 Oct 2024to 30 Sep 2032
- Phase
- Phase 3
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
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- 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)
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- 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
114 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
114 sites in 10 countries
United States54 sites, 52 recruiting
- 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
- Terminated
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
Creve Coeur, Missouri, 63141
- Recruiting
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
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
- Terminated
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12603
- Recruiting
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
Japan17 sites, 17 recruiting
- 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
Spain11 sites, 11 recruiting
- 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
France10 sites, 10 recruiting
- 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
South Korea7 sites, 7 recruiting
- 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
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
Czechia5 sites, 5 recruiting
- 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
Canada4 sites, 4 recruiting
- 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
Poland3 sites, 3 recruiting
- 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
Italy2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted19 Jul 2024
- Study start1 Oct 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Risk Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceutical
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
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No