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Non-muscle Invasive Bladder Cancer With Carcinoma in SituPhase 3ABLE-22NCT06545955

A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

A Phase 3 study testing Nadofaragene Firadenovec, Gemcitabine and Docetaxel in people with Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, run by Ferring Pharmaceuticals at 81 sites in 8 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

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nadofaragene Firadenovec, Gemcitabine and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
81 sitesin 8 countries
Study dates
1 Oct 2024to 31 Dec 2030
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, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease.
  • For T1 disease biopsies should contain muscle fibres.
  • Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to participants with high-grade non-muscle invasive bladder cancer (NMIBC) who are unlikely to benefit from and who will not be receiving further intravesical BCG. The term "BCG-Unresponsive" includes participants who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. The following criteria define the participants who may be included in the trial:
  • Have received at least 2 courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 of 3 instillations of maintenance BCG, or at least 2 of 6 instillations of a second induction course, where maintenance BCG is not given.
  • o Exception: those who have T1 high-grade disease at 1st evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression
  • At the time of tumour recurrence, participants with CIS alone or high-grade Ta/T1 with CIS should be within 12 months of last exposure to BCG
Show all 17Show fewer
  • No maximum limit to the amount of BCG administered
  • All visible papillary tumours must be resected and those with persistent T1 disease on transurethral resection of bladder tumour (TURBT) should undergo an additional re-TURBT within 14 to 70 days prior to beginning trial treatment. Obvious areas of CIS should also be fulgurated
  • Eastern Cooperative Oncology Group (ECOG) status ≤2
  • Aged ≥18 years at the time of consent
  • Available for the whole duration of the trial
  • Life expectancy >2 years, in the opinion of the investigator
  • Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumour by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or magnetic resonance imaging (MRI) with or without urogram performed within 6 months of enrolment. Absence of locally advanced disease as assessed by CT scan or MRI
  • Participants who elect not to undergo cystectomy
  • Participants with prostate cancer on active surveillance at low risk for progression are permitted to be included into the trial at the discretion of the investigator
  • Females of reproductive potential must have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraception during treatment with the investigational medicinal product and for 6 months following the last dose. Otherwise, female participants must be post-menopausal (no menstrual period for a minimum of 12 months, as confirmed by follicle-stimulating hormone levels) or surgically sterile
  • Male subjects must be willing to use a male condom and effective contraception during sex throughout the treatment period and for 3 months following the last dose.

Who cannot join

  • Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive disease include but are not limited to:
  • Presence of lymphovascular invasion and / or micropapillary, sarcomatoid, plasmacytoid and / or neuroendocrine disease as shown in the histology of the biopsy sample
  • Participants with CIS+T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumour
  • Current systemic therapy for bladder cancer other than investigational medicinal products used in randomisation arm
  • Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non interventional study does not apply) within 1 month prior to screening
  • Current or prior pelvic external beam radiotherapy within 2 years of screening
Show all 9Show fewer
  • Prior treatment with nadofaragene firadenovec at any time
  • Prior systemic therapy for bladder cancer at any time
  • Prior intravesical chemotherapy for the treatment of BCG-unresponsive NMIBC

Trial locations and contacts

81 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Ferring Pharmaceuticals contact

833-548-1402 (US/Canada)

disclosure@ferring.com

Ferring Pharmaceuticals contact

+1862-286-5200 (not US/Canada)

disclosure@ferring.com

81 sites in 8 countries

United States40 sites, 40 recruiting

  • Anne Arundel Urology, PA

    Annapolis, Maryland, 21401

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Georgia Urology

    Atlanta, Georgia, 30328

    Recruiting

  • Urology Austin

    Austin, Texas, 78759

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • Boise VA Medical Center

    Boise, Idaho, 83702

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    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

  • OSU Arthur James Cancer Hospital

    Columbus, Ohio, 43201

    Recruiting

  • Urology Clinics of North Texas PLLC (Dallas)

    Dallas, Texas, 75231

    Recruiting

  • University of Texas Southwestern Medical Center - Urology Clinic

    Dallas, Texas, 75390

    Recruiting

  • Advent Health

    Denver, Colorado, 80210

    Recruiting

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

    Germantown, Tennessee, 38138

    Recruiting

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

    Recruiting

  • Houston Methodist Hospital (Houston)

    Houston, Texas, 77030

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Recruiting

  • Northwell Health -The Arthur Smith Institute for Urology

    Lake Success, New York, 11042

    Recruiting

  • Colorado Urology - St. Anthony Hospital Campus

    Lakewood, Colorado, 80228

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17601

    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

  • USC Kenneth Norris Jr Cancer Hospital

    Los Angeles, California, 90080

    Recruiting

  • Atlantic Health

    Morristown, New Jersey, 07960

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

    Recruiting

  • Yale School of Medicine

    New Haven, Connecticut, 06519

    Recruiting

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

    New York, New York, 10010

    Recruiting

  • University of California, Irvine

    Orange, California, 92868

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • University of Pittsburgh Medical Center - Shadyside Medical Building

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Genesis Research, LLC - San Diego

    San Diego, California, 92123

    Recruiting

  • Sarasota Memorial Healthcare System

    Sarasota, Florida, 34239

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Recruiting

  • The Urology Group P.C.

    Southhaven, Mississippi, 38654

    Recruiting

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468

    Recruiting

  • Center for Neurosciences

    Tucson, Arizona, 85718

    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

Spain13 sites, 13 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 Clinic De Barcelona - University of Barcelona

    Barcelona, Catalonia, 08036

    Recruiting

  • Hospital Universitario Basurto

    Bilbao, Vizcaya

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004

    Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, Madrid, 28027

    Recruiting

  • Hospital Universitario 12 De Octubre (Madrid)

    Madrid, Madrid, 28041

    Recruiting

  • Universidad Autonoma de Madrid. Hospital Universitario La Paz

    Madrid, Madrid, 28046

    Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Recruiting

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

    Málaga, 29010

    Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, Navarre, 31008

    Recruiting

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

    Santander, Cantabria, 39008

    Recruiting

Other trials in Spain

France9 sites, 9 recruiting

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, New Aquitaine, 33076

    Recruiting

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000

    Recruiting

  • Hospices Civils de Lyon - Edouard Herriot Hosp.

    Lyon, Auvergne-Rhône-Alpes, 69003

    Recruiting

  • Centre Hospitaliser Universitaire de Lyon Sud

    Lyon, Rhone.Alpe, 69310

    Recruiting

  • CHU Nantes - Hotel Dieu

    Nantes, Nantes, 44093

    Recruiting

  • Centre Hospitalier Universitaire De Nimes (Nîmes)

    Nîmes, Occitanie, 30900

    Recruiting

  • Hopital La Pitie Salpetriere

    Paris, 75013

    Recruiting

  • APHP - Hopital Bichat

    Paris, Île-de-France Region, 75018

    Recruiting

  • CHU Toulouse - Hopital Rangueil

    Toulouse, Huate-Garonne, 31059

    Recruiting

Other trials in France

South Korea6 sites, 6 recruiting

  • Chonnam National University Hwasun Hospital (CNUHH) Organisa

    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

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

    Recruiting

Other trials in South Korea

Czechia5 sites, 5 recruiting

  • Kromerizska Nemocnice A S

    Kroměříž, Zlín, 76701

    Recruiting

  • Krajska Nemocnice Liberec

    Liberec, Liberec Region, 46300

    Recruiting

  • Fakultní Thomayerova Nemocnice

    Prague, Prague, 14059

    Recruiting

  • Fakultni nemocnice v Motole

    Prague, Prague, 15006

    Recruiting

  • Androgeos, spol. s r.o.

    Prague, Prague, 16000

    Recruiting

Other trials in Czechia

Canada4 sites, 4 recruiting

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

    Recruiting

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

    Hamilton, Ontario, L8N 4A6

    Recruiting

  • Centre Hospitalier de L'Universite de Montreal

    Montreal, Quebec, H2X 0A9

    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, 61731

    Recruiting

  • Medical Concierge Centrum Medyczne

    Warsaw, Woj. Mazowieckie, 02798

    Recruiting

Other trials in Poland

Denmark1 site, 1 recruiting

  • Aarhus University Hospital

    Aarhus, Central Jutland, 8200

    Recruiting

Other trials in Denmark

About this study

Official title: A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Being tested
Nadofaragene Firadenovec, Gemcitabine, Docetaxel, Pembrolizumab

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. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.

  • GemcitabineDrug

    Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.

  • DocetaxelDrug

    Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.

  • PembrolizumabDrug

    Pembrolizumab is an FDA approved immune checkpoint inhibitor which restores the anti-tumour immune response by blocking the programmed cell death protein 1 (PD-1). Pembrolizumab is administered via intravenous (IV) infusion.

Study groups in NCT06545955
Study groupRoleWhat they receive
Nadofaragene firadenovecExperimentalNadofaragene firadenovec (intravesical)
Receives: Drug: Nadofaragene Firadenovec
Nadofaragene firadenovec + gemcitabine & docetaxelExperimentalNadofaragene firadenovec (intravesical), and sequential gemcitabine and docetaxel (intravesical)
Receives: Drug: Nadofaragene Firadenovec; Drug: Gemcitabine; Drug: Docetaxel
Nadofaragene firadenovec + PembrolizumabExperimentalNadofaragene firadenovec (intravesical), and pembrolizumab (IV infusion). This arm will be closed and patients will no longer be randomised to this arm. This modification will convert ABLE-22 into a two-arm study with 1:1 randomisation between nadofaragene alone and nadofaragene + gemcitabine/docetaxel, to now N=100 in each of the 2 remaining arms. Participants already enrolled in this arm will not be impacted.
Receives: Drug: Nadofaragene Firadenovec; Drug: Pembrolizumab

What is being measured

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

  1. Complete response

    Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence).

    Measured: up to 6 months

Secondary outcomes (9)

  1. Complete response at month 3

    Complete response 3 months from first treatment

    Measured: 3 months

  2. Complete response at month 6

    Complete response 6 months from first treatment

    Measured: 6 months

  3. Durability of complete response

    Durability of complete response (defined as time from achieved CR to HG recurrence, progression or death due to any cause).

    Measured: Up to 24 months

  4. Muscle-invasive progression of disease

    Muscle-invasive progression of disease (defined as time from first treatment to first evidence of muscle-invasive disease or death)

    Measured: up to 36 months

  5. Cystectomy-free survival

    Cystectomy-free survival (defined as time from first treatment to either cystectomy or death due to any cause)

    Measured: up to 36 months

  6. Pathological staging

    Pathological staging (tumor, node, metastasis staging system) in participants at time of cystectomy

    Measured: up to 36 months

  7. Overall survival

    Overall survival (defined as time from first treatment to death due to any cause)

    Measured: up to 36 months

  8. Evidence of malignant lesions of the upper tract and/or prostatic urethra

    Evidence of malignant lesions of the upper tract and/or prostatic urethra (defined as time from first treatment to first evidence of malignant lesions).

    Measured: up to 24 months

  9. Adverse events

    Adverse events collected for nadofaragene firadenovec in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab)

    Measured: up to 36 months

Timeline

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

  1. First posted9 Aug 2024
  2. Study start1 Oct 2024
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2030 (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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545955
Sponsor's protocol ID
000434
Other IDs
U1111-1299-0176
Acronym
ABLE-22
Status last verified
Nov 2025
First submitted
6 Aug 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, Gemcitabine and Docetaxel in people with Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, run by Ferring Pharmaceuticals at 81 sites in 8 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 17 inclusion and 9 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 81 sites in United States, Spain, France, South Korea, Czechia and 3 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 (US/Canada), disclosure@ferring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (time frame: up to 6 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 NCT06545955.

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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