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NCT07106762PHASE2, PHASE3Recruiting

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

Bristol-Myers Squibb

Start Date

9/30/2025

Completion Date

11/18/2033

Summary

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must have histologically confirmed advanced urothelial carcinoma. * Participants must be eligible to receive platinum-based chemotherapy. * Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy. * Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment. * Participants must have ≥ 1 measurable lesion per RECIST v1.1. * Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria: * Participants must not have platinum-based chemotherapy exposure within 12 months. * Participants must not have received \>2 prior regimens irrespective of the setting. * Participants must not have prior ADC therapy targeting EGFR or HER3. * Participants must not have prior therapy with topoisomerase 1 inhibitor. * Participants must not have active, untreated brain metastases. * Other protocol-defined inclusion/exclusion criteria apply.

Interventions

DRUG

Iza-bren

DRUG

Cisplatin

DRUG

Gemcitabine

DRUG

Carboplatin

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Conditions

Urothelial Cancer

Locations

Local Institution - 0167

Gilbert, Arizona 85234

United States

Local Institution - 0162

Fullerton, California 92835

United States

Palo Alto Center-Palo Alto Medical Foundation Research Institute

Palo Alto, California 94304

United States

Sutter Health - Sutter Institute for Medical Research

Sacramento, California 95816

United States

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California 95817

United States

Pacific Hematology Oncology Associates

San Francisco, California 94115

United States

Sutter Santa Rosa

Santa Rosa, California 95403

United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado 80218

United States

Local Institution - 0245

Dillon, Colorado 80435

United States

Shaw Cancer Center

Edwards, Colorado 81632

United States

Sibley Memorial Hospital

Washington D.C., District of Columbia 20016

United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida 33176

United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky 40536

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Local Institution - 0195

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Local Institution - 0248

Buffalo, New York 14203

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Fairview Hospital

Cleveland, Ohio 44111

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

The James Outpatient Care West Campus

Columbus, Ohio 43221

United States

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States

Local Institution - 0141

Portland, Oregon 97239

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Local Institution - 0084

Nashville, Tennessee 37232

United States

Texas Oncology - West Texas

Abilene, Texas 79606

United States

Local Institution - 0187

Austin, Texas 78705

United States

Intermountain Medical Center

Murray, Utah 84107

United States

St George Regional Hospital Cancer Center

St. George, Utah 84790

United States

University of Virginia Health System

Charlottesville, Virginia 22903

United States

Local Institution - 0188

Norfolk, Virginia 23502

United States

Local Institution - 0200

Seattle, Washington 98101

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington Medical Center - Montlake

Seattle, Washington 98195

United States

Instituto Alexander Fleming

Caba, Buenos Aires 1426

Argentina

Hospital Británico de Buenos Aires

CABA, Buenos Aires CP1280AEB

Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Ciudad Autonoma de Buenos Aires, Buenos Aires 1419

Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D. C1199ABB

Argentina

IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

Córdoba, 5000

Argentina

Fundacion Centro Oncologico de Integración Regional

Mendoza, M5500AYB

Argentina

Macquarie University

Macquarie University, New South Wales 2109

Australia

GenesisCare North Shore

St Leonards, New South Wales 2065

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

Medizinische Universität Wien

Vienna, State of Vienna 1090

Austria

Klinik Ottakring

Vienna, State of Vienna 1160

Austria

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol 6020

Austria

ZAS Augustinus

Wilrijk, Antwerpen 2610

Belgium

AZ Maria Middelares

Ghent, Oost-Vlaanderen 9000

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

Local Institution - 0129

Salvador, Estado de Bahia 41253-190

Brazil

Local Institution - 0121

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Local Institution - 0130

Rio de Janeiro, 22451-100

Brazil

Local Institution - 0124

São Paulo, 01452-000

Brazil

Local Institution - 0020

Edmonton, Alberta T6G 1Z2

Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario K1H 8L6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

Local Institution - 0050

Beijing, Beijing Municipality 100034

China

Local Institution - 0224

Beijing, Beijing Municipality 100091

China

Local Institution - 0048

Fuzhou, Fujian 350001

China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, Fujian 350005

China

Local Institution - 0056

Xiamen, Fujian 361003

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510060

China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong 510120

China

Zhujiang Hospital

Guangzhou, Guangdong 510280

China

Local Institution - 0064

Zhengzhou, Henan 450008

China

Local Institution - 0059

Changsha, Hunan 410013

China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu 210000

China

Local Institution - 0046

Nanjing, Jiangsu 210009

China

Local Institution - 0114

Nantong, Jiangsu 226361

China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong 266003

China

Yantai Yuhuangding Hospital

Yantai, Shandong 264000

China

Local Institution - 0042

Shanghai, Shanghai Municipality 200032

China

Sichuan Cancer hospital

Chengdu, Sichuan 610041

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610066

China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality 300060

China

Local Institution - 0227

Tianjin, Tianjin Municipality 300070

China

Local Institution - 0157

Hangzhou, Zhejiang 310022

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430030

China

Local Institution - 0115

Brno, Brno-město 656 53

Czechia

Local Institution - 0146

Hradec Králové, Hradec Králové 500 05

Czechia

Local Institution - 0041

Prague, Praha 5 150 06

Czechia

Centre Antoine-Lacassagne

Nice, Alpes-Maritimes 06189

France

CHU Strasbourg-Hautepierre

Strasbourg, Alsace 67098

France

CHU de Bordeaux Hop St ANDRE

Bordeaux, Aquitaine 33075

France

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes 69373

France

CHRU de Brest

Brest, Finistère 29200

France

Hôpital Foch

Suresnes, Hauts-de-Seine 92151

France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-Atlantique 44805

France

Local Institution - 0005

Marseille, Provence-Alpes-Côte d'Azur Region 13273

France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, Puy-de-Dôme 63011

France

Gustave Roussy

Villejuif, Val-de-Marne 94800

France

Hôpital Européen Georges Pompidou

Paris, 75015

France

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region 75014

France

NCT

Heidelberg, Baden-Wurttemberg 69120

Germany

Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg 72622

Germany

TUM Klinikum

Munich, Bavaria 81675

Germany

Klinikum Nürnberg Nord

Nuremberg, Bavaria 90419

Germany

Caritas-Krankenhaus St. Josef

Regensburg, Bavaria 93053

Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony 30625

Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein 24105

Germany

Universitätsklinikum Jena

Jena, Thuringia 07747

Germany

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117

Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225

Germany

Krankenhaus Nordwest GmbH

Frankfurt, 60488

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Marienhospital Herne

Herne, 44625

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Local Institution - 0238

Cork, T12 DC4A

Ireland

Tallaght University Hospital

Dublin, D24 NR0A

Ireland

Rabin Medical Center

Petah Tikva, Central District 4941492

Israel

Yitzhak Shamir Medical Center

Ẕerifin, Central District 70300

Israel

Hadassah Medical Center

Jerusalem, Jerusalem 9112001

Israel

Rambam Health Care Campus

Haifa, Northern District 3109601

Israel

A.O.U.C. Policlinico di Bari

Bari, Apulia 70124

Italy

IRCCS AOM Azienda Ospedaliera Metropolitana

Genoa, Liguria 16132

Italy

Istituto Nazionale Tumori Regina Elena

Rome, Roma 00144

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany 56126

Italy

Istituto Oncologico Veneto IRCCS

Castelfranco Veneto, Veneto 31033

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedaliera Universitaria Federico II

Naples, 80131

Italy

Azienda Ospedaliero Universitaria di Parma

Parma, 43126

Italy

Local Institution - 0183

Kawasaki, Kanagawa 216-8511

Japan

Local Institution - 0171

Bunkyo-ku, Tokyo 1138603

Japan

Local Institution - 0169

Koto-ku, Tokyo 135-8550

Japan

Local Institution - 0179

Toyoma, Toyama 930-0194

Japan

Local Institution - 0036

Breda, North Brabant 4818 CK

Netherlands

Local Institution - 0033

Amsterdam, North Holland 1066 CX

Netherlands

Local Institution - 0031

Leeuwarden, Provincie Friesland 8934 AD

Netherlands

Akershus Universitetssykehus

Lørenskog, Akershus 1478

Norway

Sykehuset i Vestfold

Tønsberg, Vestfold 3103

Norway

Sykehuset Østfold Kalnes

Sarpsborg, Østfold fylke 1714

Norway

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj 200542

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña] 08041

Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de 28034

Spain

Fundación Instituto Valenciano de Oncología

Valencia, Valenciana, Comunitat 46009

Spain

Hospital Infanta Cristina

Badajoz, 06006

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01] 171 64

Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14] 413 45

Sweden

Local Institution - 0241

Malmö, 205 02

Sweden

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen 9007

Switzerland

Ospedale Regionale Bellinzona e Valli

Bellinzona, Canton Ticino 6500

Switzerland

Kantonsspital Graubünden

Chur, 7000

Switzerland

UniversitätsSpital Zürich

Zurich, 8091

Switzerland

Local Institution - 0243

Glasgow, Glasgow City G12 0YN

United Kingdom

St Bartholomew's Hospital

London, London, City of EC1A 7BE

United Kingdom

Royal Marsden Hospital (Sutton)

London, Sutton SM2 5PT

United Kingdom

Local Institution - 0230

Sheffield, S10 2SJ

United Kingdom