Urothelial CancerPhase 2/3NCT07106762
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
A Phase 2/3 study testing Iza-bren, Cisplatin and Gemcitabine in people with Urothelial Cancer, run by Bristol-Myers Squibb at 163 sites in 22 countries.
Trial summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- What is being tested?
- Iza-bren, Cisplatin and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 163 sitesin 22 countries
- Study dates
- 30 Sep 2025to 18 Nov 2033
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
163 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
163 sites in 22 countries
United States35 sites, 33 recruiting
- Recruiting
Texas Oncology - West Texas
Abilene, Texas, 79606
Srikar Malireddy, Site 0249, 940-691-8271
- Not yet recruiting
Local Institution - 0187
Austin, Texas, 78705
Site 0187
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Jean Hoffman-Censits, Site 0232, 267-760-5194
- Not yet recruiting
Local Institution - 0195
Boston, Massachusetts, 02215
Site 0195
- Withdrawn
Local Institution - 0248
Buffalo, New York, 14203
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
Paul Viscuse, Site 0158, 434-924-9333
- Recruiting
Fairview Hospital
Cleveland, Ohio, 44111
Shilpa Gupta, Site 0256, 216-296-5457
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Shilpa Gupta, Site 0192, 216-296-5457
- Recruiting
The James Outpatient Care West Campus
Columbus, Ohio, 43221
Lingbin Meng, Site 0161, 502-424-8792
- Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Manojkumar Bupathi, Site 0185, 303-418-7639
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Yusra Shao, Site 0168, 000-000-0000
- Withdrawn
Local Institution - 0245
Dillon, Colorado, 80435
- Recruiting
Shaw Cancer Center
Edwards, Colorado, 81632
Erin Schwab, Site 0191, 970-569-7608
- Not yet recruiting
Local Institution - 0162
Fullerton, California, 92835
Site 0162
- Not yet recruiting
Local Institution - 0167
Gilbert, Arizona, 85234
Site 0167
- Recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Zin Myint, Site 0193, 859-323-2964
- Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Shilpa Gupta, Site 0257, 216-296-5457
- Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Rohan Garje, Site 0247, 786-596-2000
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
David Gill, Site 0111, 913-568-7449
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Benjamin Garmezy, Site 0186, 713-444-7804
- Not yet recruiting
Local Institution - 0084
Nashville, Tennessee, 37232
Site 0084
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Matthew Galsky, Site 0086, 212-824-8583
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jonathan Rosenberg, Site 0088, 646-422-4461
- Not yet recruiting
Local Institution - 0188
Norfolk, Virginia, 23502
Site 0188
- Recruiting
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94304
Nitin Rohatgi, Site 0252, 000-000-0000
- Not yet recruiting
Local Institution - 0141
Portland, Oregon, 97239
Site 0141
- Recruiting
Sutter Health - Sutter Institute for Medical Research
Sacramento, California, 95816
Nitin Rohatgi, Site 0163, 000-000-0000
- Recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
Mamta Parikh, Site 0139, 916-734-3772
- Recruiting
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Nitin Rohatgi, Site 0251, 000-000-0000
- Recruiting
Sutter Santa Rosa
Santa Rosa, California, 95403
Nitin Rohatgi, Site 0254, 000-000-0000
- Not yet recruiting
Local Institution - 0200
Seattle, Washington, 98101
Site 0200
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Rosa Nadal, Site 0255, 206-606-1406
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Rosa Nadal Rios, Site 0259, 000-000-0000
- Recruiting
St George Regional Hospital Cancer Center
St. George, Utah, 84790
David Gill, Site 0253, 913-568-7449
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Jean Hoffman-Censits, Site 0250, 267-760-5194
China25 sites, 25 recruiting
- Not yet recruiting
Local Institution - 0050
Beijing, Beijing Municipality, 100034
Site 0050
- Not yet recruiting
Local Institution - 0224
Beijing, Beijing Municipality, 100091
Site 0224
- Not yet recruiting
Local Institution - 0059
Changsha, Hunan, 410013
Site 0059
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Hong Liao, Site 0065, 18908178867
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610066
Jiyan Liu, Site 0225, 8618980601768
- Not yet recruiting
Local Institution - 0048
Fuzhou, Fujian, 350001
Site 0048
- Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005
Ning Xu, Site 0060, 13235907575
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
zhuowei liu, Site 0051, 13610138571
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Yongda Liu, Site 0058, 13719007083
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Abai Xu, Site 0226
- Not yet recruiting
Local Institution - 0157
Hangzhou, Zhejiang, 310022
Site 0157
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Jiasheng Bian, Site 0184, +8615954104097
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Bin Fu, Site 0206, 13879103861
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Hongqian Guo, Site 0044, 8613605171690
- Not yet recruiting
Local Institution - 0046
Nanjing, Jiangsu, 210009
Site 0046
- Not yet recruiting
Local Institution - 0114
Nantong, Jiangsu, 226361
Site 0114
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Haitao Niu, Site 0156, 18661803117
- Not yet recruiting
Local Institution - 0042
Shanghai, Shanghai Municipality, 200032
Site 0042
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xin Yao, Site 0052, 13803000688
- Not yet recruiting
Local Institution - 0227
Tianjin, Tianjin Municipality, 300070
Site 0227
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Wei Chen, Site 0053, +8613857771505
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
Xianglin Yuan, Site 0201, 8613667241722
- Not yet recruiting
Local Institution - 0056
Xiamen, Fujian, 361003
Site 0056
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Jian Chen, Site 0205, +86(0)53-5669-1999Ex
- Not yet recruiting
Local Institution - 0064
Zhengzhou, Henan, 450008
Site 0064
Germany14 sites, 14 recruiting
- Recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
Maria De Santis, Site 0154, 004930450615137
- Recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Guenter Niegisch, Site 0076, 492118108776
- Recruiting
Krankenhaus Nordwest GmbH
Frankfurt, 60488
Mohammad-Reza Rafiyan, Site 0190, 49696014204
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Gunhild Von Amsberg, Site 0134, +4915222815585
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Philipp Ivanyi, Site 0144, 49511-53223014917966
- Recruiting
NCT
Heidelberg, Baden-Wurttemberg, 69120
Stefanie Zschaebitz, Site 0133, +49622156-3-9095
- Recruiting
Marienhospital Herne
Herne, 44625
Florian Roghmann, Site 0078, 023234990
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
Marc-Oliver Grimm, Site 0147, +49(0)36419329901
- Recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105
Severin Rodler, Site 0075, 0494315000
- Recruiting
TUM Klinikum
Munich, Bavaria, 81675
Margitta Retz, Site 0079, 498941402522
- Recruiting
Klinikum Nürnberg Nord
Nuremberg, Bavaria, 90419
Marinela Augustin, Site 0090, +49911398114729
- Recruiting
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, 72622
Tilman Todenhöfer, Site 0080, 4915201622246
- Recruiting
Caritas-Krankenhaus St. Josef
Regensburg, Bavaria, 93053
Marco Schnabel, Site 0135, 499417823510
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Friedemann Zengerling, Site 0132, +4973150058036
France12 sites, 11 recruiting
- Recruiting
CHU de Bordeaux Hop St ANDRE
Bordeaux, Aquitaine, 33075
Marine Gross-Goupil, Site 0004, +33556795679
- Recruiting
CHRU de Brest
Brest, Finistère, 29200
Benjamin Auberger, Site 0258, +33 2 98 22 33 33
- Recruiting
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, 63011
Hakim Mahammedi, Site 0003, +330473278080
- Recruiting
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Aude Flechon, Site 0006, +33478782828
- Withdrawn
Local Institution - 0005
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
- Recruiting
Centre Antoine-Lacassagne
Nice, Alpes-Maritimes, 06189
Delphine Borchiellini, Site 0009, +33492031000
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Constance THIBAULT, Site 0008, +33156092000
- Recruiting
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, 75014
Carole Helissey, Site 0007, +33144123333
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, 44805
Frederic Rolland, Site 0002, +33240679900
- Recruiting
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, 67098
Philippe Barthelemy, Site 0040, +33388116768
- Recruiting
Hôpital Foch
Suresnes, Hauts-de-Seine, 92151
Yann Alexandre VANO, Site 0223, +33146252000
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94800
Yohann Loriot, Site 0001, +33142114211
Spain11 sites, 11 recruiting
- Recruiting
Hospital Infanta Cristina
Badajoz, 06006
Marta Gonzalez Cordero, Site 0216, 3492421804048350
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Rafael Morales Barrera, Site 0221, +34-934894304
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Jose Pablo Maroto Rey, Site 0220, 34935565638
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
MARIA JOSE MENDEZ VIDAL, Site 0215, +34957011448
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Pablo Gajate Borau, Site 0213, 34913368263
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Jose Arranz Arija, Site 0214, 34914269393
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Javier Puente Vazquez, Site 0217, 34913303000x7554
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Daniel Castellano Gauna, Site 0218, 34913908307
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Ignacio Duran Martinez, Site 0222, +34942202525
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Begona Perez Valderrama, Site 0219, 34955013068
- Recruiting
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat, 46009
Maria Juan Fita, Site 0199, 34961104605
Italy9 sites, 9 recruiting
- Recruiting
A.O.U.C. Policlinico di Bari
Bari, Apulia, 70124
Mimma Rizzo, Site 0097, +390382592679
- Recruiting
Istituto Oncologico Veneto IRCCS
Castelfranco Veneto, Veneto, 31033
Marco Maruzzo, Site 0103, +390423732336
- Recruiting
IRCCS AOM Azienda Ospedaliera Metropolitana
Genoa, Liguria, 16132
Giuseppe Fornarini, Site 0099, 390105553303
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Patrizia Giannatempo, Site 0104, 390223902407
- Recruiting
Ospedale San Raffaele
Milan, 20132
Andrea Necchi, Site 0105, 390226435789
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Luigi Formisano, Site 0107, +16157397898
- Recruiting
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Sebastiano Buti, Site 0098, 390521702682
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Luca Galli, Site 0100, 050992455
- Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, Roma, 00144
Fabio Calabro, Site 0102, 0652666271
Argentina6 sites, 6 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Federico Cayol, Site 0024, 054911555933332
- Recruiting
Instituto Alexander Fleming
Caba, Buenos Aires, 1426
Juan Pablo Sade, Site 0023, 5432218900
- Recruiting
Hospital Británico de Buenos Aires
CABA, Buenos Aires, CP1280AEB
Ernesto Korbenfeld, Site 0028, 54911563819972
- Recruiting
Asociación de Beneficencia Hospital Sirio Libanés
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1419
Hernan Cutuli, Site 0026, 5491157654803
- Recruiting
IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
Córdoba, 5000
Martin Richardet, Site 0025, 5493516165267
- Recruiting
Fundacion Centro Oncologico de Integración Regional
Mendoza, M5500AYB
Mauricio Fernandez, Site 0027, 9542614666010
Belgium4 sites, 4 recruiting
- Recruiting
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Christof Vulsteke, Site 0014, +3292464646
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Sylvie Rottey, Site 0011, +3293322111
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
Pierre FRERES, Site 0012, +3243230000
- Recruiting
ZAS Augustinus
Wilrijk, Antwerpen, 2610
Tom Van den Mooter, Site 0013, +3234433011
Brazil4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0121
Porto Alegre, Rio Grande do Sul, 90610-000
Site 0121
- Not yet recruiting
Local Institution - 0130
Rio de Janeiro, 22451-100
Site 0130
- Not yet recruiting
Local Institution - 0129
Salvador, Estado de Bahia, 41253-190
Site 0129
- Not yet recruiting
Local Institution - 0124
São Paulo, 01452-000
Site 0124
Canada4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0020
Edmonton, Alberta, T6G 1Z2
Site 0020
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Ramy Saleh, Site 0017, 5149341934
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Christina Canil, Site 0021, 613737770070185
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Srikala Sridhar, Site 0016, 416-946-4501ext.2662
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, Northern District, 3109601
Avivit Peer, Site 0094, 97247776750
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Sharon Nordheimer, Site 0095, 972-544914863
- Recruiting
Rabin Medical Center
Petah Tikva, Central District, 4941492
Victoria Neiman, Site 0096, 97239378003
- Recruiting
Yitzhak Shamir Medical Center
Tsrifin, Central District, 70300
Raya Leibowitz, Site 0106, +972543719268
Japan4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0171
Bunkyo-ku, Tokyo, 1138603
Site 0171
- Not yet recruiting
Local Institution - 0183
Kawasaki, Kanagawa, 216-8511
Site 0183
- Not yet recruiting
Local Institution - 0169
Koto-ku, Tokyo, 135-8550
Site 0169
- Not yet recruiting
Local Institution - 0179
Toyoma, Toyama, 930-0194
Site 0179
Switzerland4 sites, 4 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, 6500
Ursula Vogl, Site 0117, 09118118463
- Recruiting
Kantonsspital Graubünden
Chur, 7000
Richard Cathomas, Site 0108, 41812566646
- Recruiting
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Verena Petermichl, Site 0077, +41714942922
- Recruiting
UniversitätsSpital Zürich
Zurich, 8091
Anja Lorch, Site 0148, 492118108776
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0243
Glasgow, Glasgow City, G12 0YN
Site 0243
- Recruiting
St Bartholomew's Hospital
London, London, City of, EC1A 7BE
Thomas Powles, Site 0237, 02078228498
- Recruiting
Royal Marsden Hospital (Sutton)
London, Sutton, SM2 5PT
Robert Huddart, Site 0231, 4402086613425
- Not yet recruiting
Local Institution - 0230
Sheffield, S10 2SJ
Site 0230
Australia3 sites, 3 recruiting
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Andrew Weickhardt, Site 0150, +61394965000
- Recruiting
Macquarie University
Macquarie University, New South Wales, 2109
Alison Zhang, Site 0149, +61298122956
- Recruiting
GenesisCare North Shore
St Leonards, New South Wales, 2065
Laurence Krieger, Site 0151, 61294631172
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, 6020
Renate Pichler, Site 0155, 4351250424811
- Recruiting
Medizinische Universität Wien
Vienna, State of Vienna, 1090
Kilian Gust, Site 0109, 004367761942300
- Recruiting
Klinik Ottakring
Vienna, State of Vienna, 1160
Dora Niedersuess-Beke, Site 0131, +431491502145
Czechia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0115
Brno, Brno-město, 656 53
Site 0115
- Not yet recruiting
Local Institution - 0146
Hradec Králové, Hradec Králové, 500 05
Site 0146
- Not yet recruiting
Local Institution - 0041
Prague, Praha 5, 150 06
Site 0041
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0033
Amsterdam, North Holland, 1066 CX
Site 0033
- Not yet recruiting
Local Institution - 0036
Breda, North Brabant, 4818 CK
Site 0036
- Not yet recruiting
Local Institution - 0031
Leeuwarden, Provincie Friesland, 8934 AD
Site 0031
Norway3 sites, 3 recruiting
- Recruiting
Akershus Universitetssykehus
Lørenskog, Akershus, 1478
Khanh Vu, Site 0239, +4767969079
- Recruiting
Sykehuset Østfold Kalnes
Sarpsborg, Østfold fylke, 1714
Corina Emilia Idu, Site 0246, 4796834141
- Recruiting
Sykehuset i Vestfold
Tønsberg, Vestfold, 3103
Marius Taran, Site 0242, 000-000-0000
Romania3 sites, 3 recruiting
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0066, 40745646368
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
Michael Schenker, Site 0067, 40727774974
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Teodora Alexa-Stratulat, Site 0072, 40757064004
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], 413 45
Emma Mangelus, Site 0234, 0046722-035659
- Not yet recruiting
Local Institution - 0241
Malmö, 205 02
Site 0241
- Recruiting
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01], 171 64
Fernanda Costa Svedman, Site 0235, 46851770000
Ireland2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0238
Cork, T12 DC4A
Site 0238
- Recruiting
Tallaght University Hospital
Dublin, D24 NR0A
Ray McDermott, Site 0236, 35314144208
About this study
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
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
- Conditions
- Urothelial Cancer
- Being tested
- Iza-bren, Cisplatin, Gemcitabine, Carboplatin
- Keywords
- Bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iza-brenDrug
Also called BMS-986507, BL-B01D1, Izalontamab brengitecan
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
GemcitabineDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Iza-bren |
| Arm B | Experimental | Not described Receives: Drug: Iza-bren |
| Arm C | Active comparator | Not described Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin |
| Arm D | Experimental | Not described Receives: Drug: Iza-bren |
| Arm E | Active comparator | Not described Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Measured: Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Measured: Up to 5 years
Phase 3: Overall Survival (OS)
Measured: Up to 5 years
Secondary outcomes (14)
Phase 2: Objective Response (OR)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator
Measured: Up to 5 years
Phase 2: PFS
Assessed using RECIST v1.1 by investigator
Measured: Up to 5 years
Phase 2: Duration of Response (DOR)
Assessed using RECIST v1.1 by investigator
Measured: Up to 5 years
Phase 2: Time to Response (TTR)
Assessed using RECIST v1.1 by investigator
Measured: Up to 5 years
Phase 2: OS
Measured: Up to 5 years
Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration
Measured: Up to 5 years
Phase 2: Iza-bren total antibody concentration
Measured: Up to 5 years
Phase 2: Iza-bren Ed-04 payload concentration
Measured: Up to 5 years
Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)
Measured: Up to 5 years
Phase 2: Iza-bren trough observed concentration (Ctrough)
Measured: Up to 5 years
Phase 3: OR
As per RECIST v1.1 by BICR
Measured: Up to 5 years
Phase 3: DoR
As per RECIST v1.1 by BICR
Measured: Up to 5 years
Phase 3: TTR
As per RECIST v1.1 by BICR
Measured: Up to 5 years
Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start30 Sep 2025
- Primary completion26 Jan 2029 (estimated)
- Study completion18 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106762
- Sponsor's protocol ID
- CA244-0012
- Other IDs
- EU CTR, WHO
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07106762
- Acronym / sponsor ID
- CA244-0012
- Conditions
- Urothelial Cancer
- Keywords
- Bladder cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 26 Jan 2029 (estimated)
- Study completion
- 18 Nov 2033 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Iza-bren |
| Arm B | Experimental | Drug: Iza-bren |
| Arm C | Active comparator | Drug: Cisplatin, Drug: Gemcitabine, Drug: Carboplatin |
| Arm D | Experimental | Drug: Iza-bren |
| Arm E | Active comparator | Drug: Cisplatin, Drug: Gemcitabine, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iza-brenAlso: BMS-986507, BL-B01D1, Izalontamab brengitecanSpecified dose on specified days | Drug | Arm A, Arm B, Arm D |
| CisplatinSpecified dose on specified days | Drug | Arm C, Arm E |
| GemcitabineSpecified dose on specified days | Drug | Arm C, Arm E |
| CarboplatinSpecified dose on specified days | Drug | Arm C, Arm E |
Primary outcome
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Time frame: Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
Time frame: Up to 5 years
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Phase 3: Overall Survival (OS)
Time frame: Up to 5 years
14 secondary outcomes
Phase 2: Objective Response (OR)
Time frame: Up to 5 years
Phase 2: PFS
Time frame: Up to 5 years
Phase 2: Duration of Response (DOR)
Time frame: Up to 5 years
Phase 2: Time to Response (TTR)
Time frame: Up to 5 years
Phase 2: OS
Time frame: Up to 5 years
Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration
Time frame: Up to 5 years
Phase 2: Iza-bren total antibody concentration
Time frame: Up to 5 years
Phase 2: Iza-bren Ed-04 payload concentration
Time frame: Up to 5 years
Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)
Time frame: Up to 5 years
Phase 2: Iza-bren trough observed concentration (Ctrough)
Time frame: Up to 5 years
Phase 3: OR
Time frame: Up to 5 years
Phase 3: DoR
Time frame: Up to 5 years
Phase 3: TTR
Time frame: Up to 5 years
Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
163 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Iza-bren, Cisplatin and Gemcitabine in people with Urothelial Cancer, run by Bristol-Myers Squibb at 163 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 163 sites in United States, China, Germany, France, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 (time frame: Approximately 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.