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RECRUITING
NCT07106762
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Iza-bren

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

DRUG

Gemcitabine

Specified dose on specified days

DRUG

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