LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
Start Date
4/22/2021
Completion Date
11/30/2028
Summary
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.
Detailed Description
EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response following delivery of the study gene therapy to the bladder urothelium. This approach of local administration through bladder instillation has the potential to induce a potent immune response exclusively at the site of the tumor, resulting in greater therapeutic benefit while reducing undesirable systemic toxicity. Eligible BCG-unresponsive NMIBC with CIS patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients will be enrolled in Phase 2 into separate cohorts include: BCG-naïve patients or BCG-exposed (incompletely treated) patients with Carcinoma in situ (CIS), and BCG-unresponsive HG Ta/T1 papillary disease without CIS. Patients will be treated for up to four 12-week cycles of study drug instillation doses and assessments with follow up assessments. Patients with complete response following four treatment cycles will enter up to 8 maintenance treatment cycles.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
EG-70 (phase 1)
EG-70 (phase 2) Master Protocol
Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
Conditions
Locations
The University of Alabama at Birmingham Clinical Research Unit (CRU)
Birmingham, Alabama 35249
United States
Mayo Clinic
Scottsdale, Arizona 85259
United States
Urological Associates of South Arizona
Tucson, Arizona 85715
United States
Arkansas Urology
Little Rock, Arkansas 72211
United States
University of California - Irvine Medical Center
Irvine, California 92697
United States
UC San Diego Moores Cancer Center
La Jolla, California 92037
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Tower Urology
Los Angeles, California 90048
United States
Om Research
San Diego, California 92123
United States
Colorado Clinical Research
Lakewood, Colorado 80228
United States
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia 20037
United States
University of Florida
Jacksonville, Florida 32209
United States
Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics
Miami, Florida 33136
United States
Emory University
Atlanta, Georgia 30322
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia 30912
United States
Urology of Indiana
Greenwood, Indiana 46143
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
John Hopkins Hospital
Baltimore, Maryland 21287
United States
Chesapeake Urology Research Associates
Hanover, Maryland 21076
United States
Brigham and Women's Hospital
Boston, Massachusetts 45227
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Corewell Health Medical Group and Spectrum Health Hospitals
Grand Rapids, Michigan 49503
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
New Jersey Urology, LLC
Voorhees Township, New Jersey 08043
United States
Albany Medical College
Albany, New York 12208
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Mount Sinai Medical Center
New Haven, New York 10029
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Associated Medical Professionals of NY,
Syracuse, New York 13210
United States
UNC Chapel Hill Hospital
Chapel Hill, North Carolina 27514
United States
Duke Health - Duke Cancer Center
Durham, North Carolina 27710
United States
Associated Urologists of North Carolina
Raleigh, North Carolina 27612
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
Central Ohio Urology Group
Gahanna, Ohio 43230
United States
Clinical Research Solutions - Helios Clinical Research
Middleburg Heights, Ohio 44130
United States
Oregon Health & Science University (OHSU)
Portland, Oregon 97239
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United States
Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Vanderbilt Univerity Medical Center
Nashville, Tennessee 37232
United States
Urology Austin
Austin, Texas 78745
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Houston Metro Urology
Houston, Texas 77027
United States
Houston Methodist Hospital - Department of Urology
Houston, Texas 77030
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903
United States
Froedtert Hospital / Medical College of Wisconsin
Milwaukee, Wisconsin 52336
United States
Sydney Adventist Hospital
Wahroonga, New South Wales 2076
Australia
Gold Coast University Hospital
Southport, Queensland 4215
Australia
Icon Cancer Center Windsor Gardens
Windsor Gardens, South Australia 5087
Australia
Prostate Cancer Centre
Calgary, Alberta T2V1P9
Canada
Vancouver Prostate Centre
Vancouver, British Columbia V5Z1M9
Canada
Nova Scotia Health Authority
Halifax, Nova Scotia B3H2Y9
Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
McGill University Health Center - Glen site
Montreal, Quebec H4A3J1
Canada
CHUM Centre Hospitalier de l Universite de Montreal
Montreal, Quebec
Canada
CHU d'Angers
Angers, 49933
France
CHU Bordeaux Pellegrin
Bordeaux, 33076
France
lnstitut Bergonie 229 Cour de l'Argonne
Bordeaux, 33076
France
CHU de Lille
Lille, 59000
France
Hospices Civils de Lyon
Lyon, 69002
France
Hopital Bichat Claude-Bernard
Paris, 75018
France
CHU de Rauen- Hopital Charles Nicolle
Rouen, 76031
France
Klinik fur Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie Universitatsklinikum Koln (AOR)
Cologne, 50937
Germany
Urologicum Duisburg
Duisburg, 47169
Germany
Universitaetsklinikum Erlangen
Erlangen, 91054
Germany
Urologie Neandertal Mettmann
Mettmann, 40822
Germany
Studienpraxis Urologie
Nürtingen, 72622
Germany
Universitaetsklinikum Tubingen
Tübingen, 72076
Germany
Clinic Unit of Urology, IRCCS Ospedale San Raffaele
Milan, MI 20132
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131
Italy
Fondazione Policlinico Universitario "A.Gemelli" IRCCS, Largo
Rome, 00168
Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, 00189
Italy
UOC Urologia, IFO- lstituto Tumori "Regina Elena"
Rome, 53 00144
Italy
Ospedelae Molinette San Giovanni Battista Di Torino
Torino, 10126
Italy
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do 13620
South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do 58128
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
The Catholic University of Korea, Soul St. Mary's Hospital
Seoul, 06591
South Korea
IOB - Hospital Quironsalud Barcelona
Barbera Del Valles, 5-7
Spain
Fundacio Puigvert
Barcelona, 08025
Spain
Hospital Clinic Barcelona
Barcelona, 08036
Spain
Hospital Germans Trias i Pujol
Barcelona, 08916
Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Quironsalud Madrid (Next Oncology)
Madrid, 28223
Spain
Hospital Universitario Infanta Sofia
Madrid, 28702
Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008
Spain
Hospital Universitario Marqués de Valdecilla,
Santander, 39008
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
China Medical University Hospital
Taichung, 40447
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
Chi Mei Medical Center
Tainan, 71004
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
United Kingdom