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

NCT ID NCT06545955

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

Contacts and locations

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Study contacts

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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
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