RecruitingPhase III🇵🇱 PolandEN original

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzona diagnoza raka pęcherza moczowego w stadium CIS (możliwie ze zmianami Ta/T1 wysokiego stopnia)
  • Brak odpowiedzi na co najmniej 2 serie leczenia BCG w ciągu ostatnich 12 miesięcy
  • Całkowite usunięcie wszystkich widocznych zmian nowotworowych przed badaniem
  • Wiek co najmniej 18 lat
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG ≤2)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (76)

Center for Neurosciences

Tucson, United States

Arkansas Urology, North Little Rock

Little Rock, United States

American Institute of Research

Los Angeles, United States

USC Kenneth Norris Jr Cancer Hospital

Los Angeles, United States

University of California, Irvine

Orange, United States

Genesis Research, LLC - San Diego

San Diego, United States

Advent Health

Denver, United States

Colorado Urology - St. Anthony Hospital Campus

Lakewood, United States

Yale School of Medicine

New Haven, United States

Medstar Georgetown University Hospital

Washington D.C., United States

Sarasota Memorial Healthcare System

Sarasota, United States

Emory University

Atlanta, United States

Georgia Urology

Atlanta, United States

Boise VA Medical Center

Boise, United States

NextStage Clinical Research

Lisle, United States

Indiana University

Indianapolis, United States

Wichita Urology Group

Wichita, United States

Anne Arundel Urology, PA

Annapolis, United States

Chesapeake Urology Research Associates

Hanover, United States

Atlantic Health

Morristown, United States

Roswell Park Cancer Institute

Buffalo, United States

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

Cheektowaga, United States

Northwell Health -The Arthur Smith Institute for Urology

Lake Success, United States

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

New York, United States

James J. Peters VA Medical Center

The Bronx, United States

University of Cincinnati

Cincinnati, United States

OSU Arthur James Cancer Hospital

Columbus, United States

MidLantic Urology

Bala-Cynwyd, United States

Keystone Urology Specialists

Lancaster, United States

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

Philadelphia, United States

University of Pittsburgh Medical Center - Shadyside Medical Building

Pittsburgh, United States

Carolina Urologic Research Center

Myrtle Beach, United States

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

Germantown, United States

Urology Associates, P.C.

Nashville, United States

Urology Austin

Austin, United States

Urology Clinics of North Texas PLLC (Dallas)

Dallas, United States

University of Texas Southwestern Medical Center - Urology Clinic

Dallas, United States

Houston Methodist Hospital (Houston)

Houston, United States

Virginia Mason Medical Center

Seattle, United States

Prostate Cancer Centre

Calgary, Canada

University Health Network UHN - Princess Margaret Cancer Centre

Toronto, Canada

Centre Hospitalier de L'Universite de Montreal

Montreal, Canada

Krajska Nemocnice Liberec

Liberec, Czechia

Fakultní Thomayerova Nemocnice

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Androgeos, spol. s r.o.

Prague, Czechia

Kromerizska Nemocnice A S

Kroměříž, Czechia

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, France

Hospices Civils de Lyon - Edouard Herriot Hosp.

Lyon, France

CHU Toulouse - Hopital Rangueil

Toulouse, France

CHU Nantes - Hotel Dieu

Nantes, France

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France

Centre Hospitalier Universitaire De Nimes (Nîmes)

Nîmes, France

Centre Hospitaliser Universitaire de Lyon Sud

Lyon, France

Hopital La Pitie Salpetriere

Paris, France

APHP - Hopital Bichat

Paris, France

IN-VIVO Bydgoszcz

Bydgoszcz, Poland

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

Poznan, Poland

Medical Concierge Centrum Medyczne

Warsaw, Poland

Pusan National University Yangsan Hospital

Yangsan, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Santander, Spain

Hospital del Mar

Barcelona, Spain

Hospital Clinic De Barcelona - University of Barcelona

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario de A Coruna

A Coruña, Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Universitario 12 De Octubre (Madrid)

Madrid, Spain

Universidad Autonoma de Madrid. Hospital Universitario La Paz

Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Hospital Universitario Basurto

Bilbao, Spain

MD Anderson Cancer Center

Madrid, Spain

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

Málaga, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.

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