LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
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
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC. A Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rak pęcherza moczowego bez nacieków mięśniowych (nieobejmujący głębokich warstw pęcherza) z chorobą przerzutową lub bez, u których nie zadziałała wcześniejsza terapia BCG
- •Osoby, które odmówiły lub nie mogą przejść operacji usunięcia pęcherza moczowego
- •Potwierdzona choroba w badaniu patologicznym w ciągu ostatnich 12 miesięcy
- •Pacjenci, którzy poprzednio otrzymali co najmniej 2 pełne kursy leczenia BCG (z odpowiednią liczbą dawek)
- •Wiek 18 lat lub więcej
- •Kobiety w wieku rozrodczym muszą mieć ujemny test ciążowy
- •Kobiety muszą stosować skuteczne środki antykoncepcyjne, mężczyźni muszą używać prezerwatyw przez cały czas leczenia i 3 miesiące po
- •Pacjenci, którzy wcześniej dostali inne nowe leki immunologiczne i leczenie nie zadziałało (mogą być włączeni 30 dni lub 3 miesiące po zakończeniu)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (102)
The University of Alabama at Birmingham Clinical Research Unit (CRU)
Birmingham, United States
Mayo Clinic
Scottsdale, United States
Urological Associates of South Arizona
Tucson, United States
Arkansas Urology
Little Rock, United States
University of California - Irvine Medical Center
Irvine, United States
UC San Diego Moores Cancer Center
La Jolla, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
Tower Urology
Los Angeles, United States
Om Research
San Diego, United States
Colorado Clinical Research
Lakewood, United States
The George Washington Medical Faculty Associates
Washington D.C., United States
University of Florida
Jacksonville, United States
Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics
Miami, United States
Emory University
Atlanta, United States
Georgia Cancer Center at Augusta University
Augusta, United States
Urology of Indiana
Greenwood, United States
University of Kansas Medical Center
Kansas City, United States
John Hopkins Hospital
Baltimore, United States
Chesapeake Urology Research Associates
Hanover, United States
Brigham and Women's Hospital
Boston, United States
Henry Ford Health System
Detroit, United States
Corewell Health Medical Group and Spectrum Health Hospitals
Grand Rapids, United States
University of Minnesota
Minneapolis, United States
Mayo Clinic
Rochester, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States
New Jersey Urology, LLC
Voorhees Township, United States
Albany Medical College
Albany, United States
Roswell Park Cancer Institute
Buffalo, United States
Mount Sinai Medical Center
New Haven, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, United States
Associated Medical Professionals of NY,
Syracuse, United States
UNC Chapel Hill Hospital
Chapel Hill, United States
Duke Health - Duke Cancer Center
Durham, United States
Associated Urologists of North Carolina
Raleigh, United States
University of Cincinnati Medical Center
Cincinnati, United States
Central Ohio Urology Group
Gahanna, United States
Clinical Research Solutions - Helios Clinical Research
Middleburg Heights, United States
Oregon Health & Science University (OHSU)
Portland, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, United States
Urology Associates, P.C.
Nashville, United States
Vanderbilt Univerity Medical Center
Nashville, United States
Urology Austin
Austin, United States
UT Southwestern Medical Center
Dallas, United States
Houston Metro Urology
Houston, United States
Houston Methodist Hospital - Department of Urology
Houston, United States
University of Texas - MD Anderson Cancer Center
Houston, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, United States
Froedtert Hospital / Medical College of Wisconsin
Milwaukee, United States
Sydney Adventist Hospital
Wahroonga, Australia
Gold Coast University Hospital
Southport, Australia
Icon Cancer Center Windsor Gardens
Windsor Gardens, Australia
Prostate Cancer Centre
Calgary, Canada
Vancouver Prostate Centre
Vancouver, Canada
Nova Scotia Health Authority
Halifax, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada
McGill University Health Center - Glen site
Montreal, Canada
CHUM Centre Hospitalier de l Universite de Montreal
Montreal, Canada
CHU d'Angers
Angers, France
CHU Bordeaux Pellegrin
Bordeaux, France
lnstitut Bergonie 229 Cour de l'Argonne
Bordeaux, France
CHU de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
Hopital Bichat Claude-Bernard
Paris, France
CHU de Rauen- Hopital Charles Nicolle
Rouen, France
Klinik fur Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie Universitatsklinikum Koln (AOR)
Cologne, Germany
Urologicum Duisburg
Duisburg, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany
Urologie Neandertal Mettmann
Mettmann, Germany
Studienpraxis Urologie
Nürtingen, Germany
Universitaetsklinikum Tubingen
Tübingen, Germany
Clinic Unit of Urology, IRCCS Ospedale San Raffaele
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
Fondazione Policlinico Universitario "A.Gemelli" IRCCS, Largo
Rome, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Italy
UOC Urologia, IFO- lstituto Tumori "Regina Elena"
Rome, Italy
Ospedelae Molinette San Giovanni Battista Di Torino
Torino, Italy
Seoul National University Bundang Hospital
Seongnam, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Soul St. Mary's Hospital
Seoul, South Korea
IOB - Hospital Quironsalud Barcelona
Barbera Del Valles, Spain
Fundacio Puigvert
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Quironsalud Madrid (Next Oncology)
Madrid, Spain
Hospital Universitario Infanta Sofia
Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Marqués de Valdecilla,
Santander, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Trial contact
enGene clinical trials
Chris Tosone
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/8/2026.
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