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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
2026-03-31
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 (159)
Local Institution - 0167
Gilbert, Arizona, United States
Local Institution - 0162
Fullerton, California, United States
Local Institution - 0252
Palo Alto, California, United States
Local Institution - 0163
Sacramento, California, United States
Local Institution - 0139
Sacramento, California, United States
Local Institution - 0251
San Francisco, California, United States
Local Institution - 0254
Santa Rosa, California, United States
Local Institution - 0245
Dillon, Colorado, United States
Shaw Cancer Center
Edwards, Colorado, United States
Local Institution - 0250
Washington D.C., District of Columbia, United States
Local Institution - 0247
Miami, Florida, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Local Institution - 0232
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
Local Institution - 0161
Columbus, Ohio, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States
Local Institution - 0141
Portland, Oregon, United States
Local Institution - 0186
Nashville, Tennessee, United States
Local Institution - 0084
Nashville, Tennessee, United States
Local Institution - 0249
Abilene, Texas, United States
Local Institution - 0187
Austin, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Local Institution - 0253
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
Local Institution - 0255
Seattle, Washington, United States
Local Institution - 0028
CABA, Buenos Aires, Argentina
Local Institution - 0023
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0024
ABB, Buenos Aires F.D., Argentina
Local Institution - 0026
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0025
Córdoba, Argentina
Local Institution - 0027
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 Universitaet Innsbruck
Innsbruck, Tyrol, Austria
Medizinische Universität Wien
Vienna, Vienna, Austria
Klinik Ottakring
Vienna, Vienna, 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
Local Institution - 0060
Fuzhou, Fujian, China
Local Institution - 0056
Xiamen, Fujian, China
Local Institution - 0051
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital
Guangzhou, Guangdong, China
Local Institution - 0201
Wuhan, Hubei, 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
Local Institution - 0206
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Local Institution - 0156
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Local Institution - 0042
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Local Institution - 0052
Tianjin, Tianjin Municipality, China
Local Institution - 0227
Tianjin, Tianjin Municipality, China
Local Institution - 0157
Hangzhou, Zhejiang, China
Local Institution - 0053
Wenzhou, Zhejiang, China
Local Institution - 0064
Zhengzhou, China
Local Institution - 0115
Brno, Brno-město, Czechia
Local Institution - 0146
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0041
Prague, Praha 5, Czechia
Local Institution - 0009
Nice, Alpes-Maritimes, France
Local Institution - 0040
Strasbourg, Alsace, France
CHU de Bordeaux Hop St ANDRE
Bordeaux, Aquitaine, France
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Local Institution - 0258
Brest, Finistère, France
Hôpital Foch
Suresnes, Hauts-de-Seine, France
Local Institution - 0002
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0005
Marseille, Provence-Alpes-Côte d'Azur Region, France
Local Institution - 0003
Clermont-Ferrand, Puy-de-Dôme, France
Local Institution - 0001
Villejuif, Val-de-Marne, France
Local Institution - 0008
Paris, France
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, France
NCT
Heidelberg, Baden-Wurttemberg, Germany
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
TUM Klinikum
Munich, Bavaria, Germany
Klinikum Nürnberg Nord
Nuremberg, Bavaria, Germany
Caritas-Krankenhaus St. Josef
Regensburg, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
Krankenhaus Nordwest GmbH
Frankfurt, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Marienhospital Herne
Herne, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Local Institution - 0238
Cork, Ireland
Local Institution - 0236
Dublin, Ireland
Rabin Medical Center
Petah Tikva, Central District, Israel
Local Institution - 0106
Ẕerifin, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
A.O.U.C. Policlinico di Bari
Bari, Apulia, Italy
Ospedale San Martino
Genoa, Liguria, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Roma, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Istituto Oncologico Veneto IRCCS
Castelfranco Veneto, Veneto, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Local Institution - 0183
Kawasaki, Kanagawa, Japan
Local Institution - 0171
Bunkyo-ku, Tokyo, Japan
Local Institution - 0169
Koto-ku, Tokyo, Japan
Local Institution - 0179
Toyoma, Toyama, Japan
Local Institution - 0036
Breda, North Brabant, Netherlands
Local Institution - 0033
Amsterdam, North Holland, Netherlands
Local Institution - 0031
Leeuwarden, Provincie Friesland, Netherlands
Akershus Universitetssykehus
Lørenskog, Akershus, Norway
Sykehuset i Vestfold
Tønsberg, Vestfold, Norway
Sykehuset Østfold Kalnes
Sarpsborg, Østfold fylke, Norway
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Institutul Regional de Oncologie
Iași, Romania
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0199
Valencia, Valenciana, Comunitat, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Local Institution - 0235
Solna, Stockholms Län [se-01], Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0241
Malmo, Sweden
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubünden
Chur, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Local Institution - 0243
Glasgow, Glasgow City, United Kingdom
St Bartholomew's Hospital
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton)
London, Sutton, United Kingdom
Local Institution - 0230
Sheffield, United Kingdom