RecruitingPhase 3NCT06545955

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, 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)

Sponsor

Ferring Pharmaceuticals

Enrollment

250 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

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. 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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing nadofaragene firadenovec — a gene therapy delivered directly into the bladder — alone or combined with chemotherapy or immunotherapy, in people with high-grade bladder cancer that has not responded to BCG (a standard treatment) and has not invaded the muscle layer. **You may be eligible if...** - You have been diagnosed with high-grade non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS) - You have had at least 2 courses of BCG treatment within the last 12 months and your cancer has not responded or has come back - You are not a candidate for or are trying to avoid bladder removal surgery **You may NOT be eligible if...** - Your bladder cancer has grown into the muscle wall - You have had prior treatment with nadofaragene firadenovec - You have active uncontrolled infections or serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNadofaragene Firadenovec

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.

DRUGGemcitabine

Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.

DRUGDocetaxel

Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.

DRUGPembrolizumab

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.

Locations(66)

American Institute of Research

Los Angeles, California, United States

USC Kenneth Norris Jr Cancer Hospital

Los Angeles, California, United States

University of California, Irvine

Orange, California, United States

Genesis Research, LLC - San Diego

San Diego, California, United States

Advent Health

Denver, Colorado, United States

Colorado Urology - St. Anthony Hospital Campus

Lakewood, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

Medstar Georgetown University Hospital

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

Sarasota Memorial Healthcare System

Sarasota, Florida, United States

Emory University

Atlanta, Georgia, United States

Georgia Urology

Atlanta, Georgia, United States

Boise VA Medical Center

Boise, Idaho, United States

NextStage Clinical Research

Lisle, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Wichita Urology Group

Wichita, Kansas, United States

Anne Arundel Urology, PA

Annapolis, Maryland, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Atlantic Health

Morristown, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

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

Cheektowaga, New York, United States

Northwell Health -The Arthur Smith Institute for Urology

Lake Success, New York, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

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

Philadelphia, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Associates, P.C.

Nashville, Tennessee, United States

Urology Austin

Austin, Texas, United States

Urology Clinics of North Texas PLLC (Dallas)

Dallas, Texas, United States

University of Texas Southwestern Medical Center - Urology Clinic

Dallas, Texas, United States

Houston Methodist Hospital (Houston)

Houston, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Prostate Cancer Centre

Calgary, Alberta, Canada

Centre Hospitalier de L'Universite de Montreal

Montreal, Quebec, Canada

Krajska Nemocnice Liberec

Liberec, Liberec Region, Czechia

Fakultní Thomayerova Nemocnice

Prague, Prague, Czechia

Fakultni nemocnice v Motole

Prague, Prague, Czechia

Androgeos, spol. s r.o.

Prague, Prague, Czechia

Kromerizska Nemocnice A S

Kroměříž, Zlín, Czechia

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Hospices Civils de Lyon - Edouard Herriot Hosp.

Lyon, Auvergne-Rhône-Alpes, France

CHU Toulouse - Hopital Rangueil

Toulouse, Huate-Garonne, France

CHU Nantes - Hotel Dieu

Nantes, Nantes, France

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, New Aquitaine, France

Centre Hospitalier Universitaire De Nimes (Nîmes)

Nîmes, Occitanie, France

Centre Hospitaliser Universitaire de Lyon Sud

Lyon, Rhone.Alpe, France

Hopital La Pitie Salpetriere

Paris, France

APHP - Hopital Bichat

Paris, Île-de-France Region, France

IN-VIVO Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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

Poznan, Wielkopolska, Poland

Medical Concierge Centrum Medyczne

Warsaw, Woj. Mazowieckie, Poland

Korea University Anam Hospital

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

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

Santander, Cantabria, Spain

Hospital del Mar

Barcelona, Catalonia, Spain

Hospital Clinic De Barcelona - University of Barcelona

Barcelona, Catalonia, Spain

Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain

Hospital Universitario de A Coruna

A Coruña, Galicia, Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Madrid, Spain

Hospital Universitario 12 De Octubre (Madrid)

Madrid, Madrid, Spain

Universidad Autonoma de Madrid. Hospital Universitario La Paz

Madrid, Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, Spain

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain

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

Málaga, Spain

View Full Details on ClinicalTrials.gov

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NCT06545955

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