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New gene therapy combo could offer bladder cancer patients an alternative to surgery

NCT ID NCT06545955

Disease control Sponsor: Ferring Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This phase 3 trial is testing a gene therapy called nadofaragene firadenovec, given directly into the bladder, either alone or combined with chemotherapy or immunotherapy. It is for people with a type of bladder cancer that has not responded to standard BCG therapy. The study aims to see if these treatments can eliminate the cancer and keep it from coming back, potentially offering a less invasive option than bladder removal surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nadofaragene firadenovec (gene therapy), gemcitabine (chemotherapy), docetaxel (chemotherapy), pembrolizumab (immunotherapy)
What this could lead to
If successful, this could offer a new treatment option for people with bladder cancer that hasn't responded to standard therapy, potentially delaying or avoiding bladder removal surgery.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. The gene therapy is new and long-term safety and effectiveness are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ non-invasive bladder urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder cancer with carcinoma in situ

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    76 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP - Hopital Bichat

    RECRUITING

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

  • Advent Health

    RECRUITING

    Denver, Colorado, 80210, United States

  • American Institute of Research

    RECRUITING

    Los Angeles, California, 90017, United States

  • Androgeos, spol. s r.o.

    RECRUITING

    Prague, Prague, 16000, Czechia

  • Anne Arundel Urology, PA

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Arkansas Urology, North Little Rock

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Atlantic Health

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Boise VA Medical Center

    RECRUITING

    Boise, Idaho, 83702, United States

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    RECRUITING

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

  • CHU Nantes - Hotel Dieu

    RECRUITING

    Nantes, Nantes, 44093, France

  • CHU Toulouse - Hopital Rangueil

    RECRUITING

    Toulouse, Huate-Garonne, 31059, France

  • CHU de Bordeaux - Hôpital Pellegrin

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Center for Neurosciences

    RECRUITING

    Tucson, Arizona, 85718, United States

  • Centre Hospitalier Universitaire De Nimes (Nîmes)

    RECRUITING

    Nîmes, Occitanie, 30900, France

  • Centre Hospitalier de L'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Centre Hospitaliser Universitaire de Lyon Sud

    RECRUITING

    Lyon, Rhone.Alpe, 69310, France

  • Chesapeake Urology Research Associates

    RECRUITING

    Hanover, Maryland, 21076, United States

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    RECRUITING

    Pamplona, Navarre, 31008, Spain

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

    RECRUITING

    Poznan, Wielkopolska, 61731, Poland

  • Colorado Urology - St. Anthony Hospital Campus

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fakultni nemocnice v Motole

    RECRUITING

    Prague, Prague, 15006, Czechia

  • Fakultní Thomayerova Nemocnice

    RECRUITING

    Prague, Prague, 14059, Czechia

  • Genesis Research, LLC - San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • Georgia Urology

    RECRUITING

    Atlanta, Georgia, 30328, United States

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

    RECRUITING

    Cheektowaga, New York, 14225, United States

  • Hopital La Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

  • Hospices Civils de Lyon - Edouard Herriot Hosp.

    RECRUITING

    Lyon, Auvergne-Rhône-Alpes, 69003, France

  • Hospital Clinic De Barcelona - University of Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitario 12 De Octubre (Madrid)

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Basurto

    RECRUITING

    Bilbao, Vizcaya, Spain

  • Hospital Universitario Fundacion Alcorcon

    RECRUITING

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario de A Coruna

    RECRUITING

    A Coruña, Galicia, 15006, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • Houston Methodist Hospital (Houston)

    RECRUITING

    Houston, Texas, 77030, United States

  • IN-VIVO Bydgoszcz

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • James J. Peters VA Medical Center

    RECRUITING

    The Bronx, New York, 10468, United States

  • Keystone Urology Specialists

    RECRUITING

    Lancaster, Pennsylvania, 17601, United States

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Seoul, 02841, South Korea

  • Krajska Nemocnice Liberec

    RECRUITING

    Liberec, Liberec Region, 46300, Czechia

  • Kromerizska Nemocnice A S

    RECRUITING

    Kroměříž, Zlín, 76701, Czechia

  • MD Anderson Cancer Center

    RECRUITING

    Madrid, 28033, Spain

  • Medical Concierge Centrum Medyczne

    RECRUITING

    Warsaw, Woj. Mazowieckie, 02798, Poland

  • Medstar Georgetown University Hospital

    RECRUITING

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

  • MidLantic Urology

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • NextStage Clinical Research

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Northwell Health -The Arthur Smith Institute for Urology

    RECRUITING

    Lake Success, New York, 11042, United States

  • OSU Arthur James Cancer Hospital

    RECRUITING

    Columbus, Ohio, 43201, United States

  • Prostate Cancer Centre

    RECRUITING

    Calgary, Alberta, T2V 1P9, Canada

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, 06351, South Korea

  • Sarasota Memorial Healthcare System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, Songpa-gu, 03080, South Korea

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

    RECRUITING

    Málaga, 29010, Spain

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

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • USC Kenneth Norris Jr Cancer Hospital

    RECRUITING

    Los Angeles, California, 90080, United States

  • Universidad Autonoma de Madrid. Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • University Health Network UHN - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center - Shadyside Medical Building

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center - Urology Clinic

    RECRUITING

    Dallas, Texas, 75390, United States

  • Urology Associates, P.C.

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    RECRUITING

    Austin, Texas, 78759, United States

  • Urology Clinics of North Texas PLLC (Dallas)

    RECRUITING

    Dallas, Texas, 75231, United States

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

    RECRUITING

    New York, New York, 10010, United States

  • Virginia Mason Medical Center

    RECRUITING

    Seattle, Washington, 98101, United States

  • Wichita Urology Group

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Yale School of Medicine

    RECRUITING

    New Haven, Connecticut, 06519, United States

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