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Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Sponsor: Bristol-Myers Squibb
Summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Official title: IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
470
Start Date
2025-09-30
Completion Date
2033-11-18
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Iza-bren
Specified dose on specified days
Cisplatin
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Carboplatin
Specified dose on specified days
Locations (163)
Local Institution - 0167
Gilbert, Arizona, United States
Local Institution - 0162
Fullerton, California, United States
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States
Sutter Health - Sutter Institute for Medical Research
Sacramento, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Sutter Santa Rosa
Santa Rosa, California, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Local Institution - 0245
Dillon, Colorado, United States
Shaw Cancer Center
Edwards, Colorado, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Local Institution - 0195
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution - 0248
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The James Outpatient Care West Campus
Columbus, Ohio, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States
Local Institution - 0141
Portland, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Local Institution - 0084
Nashville, Tennessee, United States
Texas Oncology - West Texas
Abilene, Texas, United States
Local Institution - 0187
Austin, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
St George Regional Hospital Cancer Center
St. George, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Local Institution - 0188
Norfolk, Virginia, United States
Local Institution - 0200
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Instituto Alexander Fleming
Caba, Buenos Aires, Argentina
Hospital Británico de Buenos Aires
CABA, Buenos Aires, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
Córdoba, Argentina
Fundacion Centro Oncologico de Integración Regional
Mendoza, Argentina
Macquarie University
Macquarie University, New South Wales, Australia
GenesisCare North Shore
St Leonards, New South Wales, Australia
Austin Health
Heidelberg, Victoria, Australia
Medizinische Universität Wien
Vienna, State of Vienna, Austria
Klinik Ottakring
Vienna, State of Vienna, Austria
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, Austria
ZAS Augustinus
Wilrijk, Antwerpen, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Local Institution - 0129
Salvador, Estado de Bahia, Brazil
Local Institution - 0121
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0130
Rio de Janeiro, Brazil
Local Institution - 0124
São Paulo, Brazil
Local Institution - 0020
Edmonton, Alberta, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Local Institution - 0050
Beijing, Beijing Municipality, China
Local Institution - 0224
Beijing, Beijing Municipality, China
Local Institution - 0048
Fuzhou, Fujian, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Local Institution - 0056
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital
Guangzhou, Guangdong, China
Local Institution - 0064
Zhengzhou, Henan, China
Local Institution - 0059
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Local Institution - 0046
Nanjing, Jiangsu, China
Local Institution - 0114
Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Local Institution - 0042
Shanghai, Shanghai Municipality, China
Sichuan Cancer hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Local Institution - 0227
Tianjin, Tianjin Municipality, China
Local Institution - 0157
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Local Institution - 0115
Brno, Brno-město, Czechia
Local Institution - 0146
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0041
Prague, Praha 5, Czechia
Centre Antoine-Lacassagne
Nice, Alpes-Maritimes, France
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, France
CHU de Bordeaux Hop St ANDRE
Bordeaux, Aquitaine, France
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, France
CHRU de Brest
Brest, Finistère, France
Hôpital Foch
Suresnes, Hauts-de-Seine, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0005
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Hôpital Européen Georges Pompidou
Paris, France
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, France
NCT
Heidelberg, Baden-Wurttemberg, Germany