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

Last updated: July 3, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

2/3

Condition

Urothelial Cancer

Bladder Cancer

Urothelial Carcinoma

Treatment

Gemcitabine

Carboplatin

Cisplatin

Clinical Study ID

NCT07106762
CA244-0012
WHO
EU CTR
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 metastaticsetting), either in combination with or sequential to another systemic therapy.

  • Participants treated only in the peri-operative setting must have relapsed within 12months 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

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.

Study Design

Total Participants: 470
Treatment Group(s): 4
Primary Treatment: Gemcitabine
Phase: 2/3
Study Start date:
September 30, 2025
Estimated Completion Date:
November 18, 2033

Connect with a study center

  • Hospital Británico de Buenos Aires

    CABA, Buenos Aires CP1280AEB
    Argentina

    Active - Recruiting

  • Local Institution - 0028

    CABA, Buenos Aires CP1280AEB
    Argentina

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  • Instituto Alexander Fleming

    Caba, Buenos Aires 1426
    Argentina

    Active - Recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1419
    Argentina

    Active - Recruiting

  • Local Institution - 0023

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
    Argentina

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  • Hospital Italiano de Buenos Aires

    ABB, Buenos Aires F.D. C1199ABB
    Argentina

    Active - Recruiting

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    ABB, Buenos Aires F.D. C1199ABB
    Argentina

    Site Not Available

  • IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

    Córdoba, 5000
    Argentina

    Active - Recruiting

  • Local Institution - 0025

    Córdoba, 5000
    Argentina

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  • Fundacion Centro Oncologico de Integración Regional

    Mendoza, M5500AYB
    Argentina

    Active - Recruiting

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    Mendoza, M5500AYB
    Argentina

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  • Macquarie University

    Macquarie University, New South Wales 2109
    Australia

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  • GenesisCare North Shore

    St Leonards, New South Wales 2065
    Australia

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    Macquarie University, New South Wales 2155400 2109
    Australia

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    St Leonards 8029783, New South Wales 2155400 2065
    Australia

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    Heidelberg, Victoria 3084
    Australia

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    Heidelberg, Victoria 3084
    Australia

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    Heidelberg 2163654, Victoria 2145234 3084
    Australia

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  • Klinik Ottakring

    Vienna, State of Vienna 1160
    Austria

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    Vienna, State of Vienna 1090
    Austria

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    Innsbruck, Tyrol 6020
    Austria

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    Innsbruck, Tyrol 6020
    Austria

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    Vienna, Vienna 1160
    Austria

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    Vienna 2761369, Vienna 2761367 1090
    Austria

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    Vienna 2761369, Vienna 2761367 1160
    Austria

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    Wilrijk, Antwerpen 2610
    Belgium

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    Wilrijk 2783615, Antwerpen 2610
    Belgium

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    Gent, Oost-Vlaanderen 9000
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    Ghent, Oost-Vlaanderen 9000
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    Ghent, Oost-Vlaanderen 9000
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    Ghent 2797656, Oost-Vlaanderen 9000
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    Ghent 2797656, Oost-Vlaanderen 9000
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    Ghent 2797656, Oost-Vlaanderen 9000
    Belgium

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    Liège, 4000
    Belgium

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    Liège 2792413, 4000
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    Salvador, Estado de Bahia 41253-190
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    Porto Alegre, Rio Grande do Sul 90610-000
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    Rio de Janeiro, 22451-100
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    Toronto, Ontario M5G 2M9
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    Montreal, Quebec H4A 3J1
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    Beijing, Beijing Municipality 100034
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    Beijing, Beijing Municipality 100091
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    Beijing 1816670, Beijing Municipality 2038349 100034
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    Fuzhou, Fujian 350001
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    Fuzhou, Fujian 350005
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    Fuzhou, Fujian 350005
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    Xiamen, Fujian 361003
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    Fuzhou 1810821, Fujian 1811017 350001
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    Guangzhou, Guangdong 510060
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    Guangzhou, Guangdong 510280
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    Guangzhou, Guangdong 510060
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    Guangzhou, Guangdong 510120
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    Guangzhou, Guangdong 510280
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    Guangzhou 1809858, Guangdong 1809935 510060
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    Guangzhou 1809858, Guangdong 1809935 510120
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    Guangzhou 1809858, Guangdong 1809935 510280
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    Zhengzhou, Henan 450008
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    Wuhan, Hubei 430030
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    Changsha, Hunan 410013
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    Nanjing, Jiangsu 210009
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    Nantong, Jiangsu 226361
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    Nanjing 1799962, Jiangsu 1806260 210000
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    Nanjing 1799962, Jiangsu 1806260 210009
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    Nanchang, Jiangxi 330006
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    Jinan, Shandong 250117
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    Qingdao, Shandong 266003
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    Qingdao, Shandong 266003
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    Yantai, Shandong 264000
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    Shanghai, Shanghai Municipality 200032
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    Chengdu, Sichuan 610041
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    Chengdu, Sichuan 610066
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    Chengdu 1815286, Sichuan 1794299 610066
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    Tianjin, Tianjin Municipality 300060
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    Tianjin, Tianjin Municipality 300070
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    Tianjin, Tianjin Municipality 300060
    China

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    Tianjin 1792947, Tianjin Municipality 1792943 300060
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    Hangzhou, Zhejiang 310022
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  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030
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    Brno, Brno-město 656 53
    Czechia

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    Hradec Králové, Hradec Králové 500 05
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    Prague, Praha 5 150 06
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  • Centre Antoine-Lacassagne

    Nice, Alpes-Maritimes 06189
    France

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    Nice, Alpes-Maritimes 06189
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    Strasbourg, Alsace 67098
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    Bordeaux, Aquitaine 33075
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    Bordeaux 3031582, Aquitaine 33075
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    Lyon Cedex08, Auvergne-Rhône-Alpes 69373
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    Lyon Cedex08, Auvergne-Rhône-Alpes 69373
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    Brest, Finistère 29200
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    Brest, Finistère 29200
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    Suresnes, Hauts-de-Seine 92151
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    Suresnes, Hauts-de-Seine 92151
    France

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  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-Atlantique 44805
    France

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    Saint-Herblain, Loire-Atlantique 44805
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    Marseille, Provence-Alpes-Côte d'Azur Region 13273
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  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, Puy-de-Dôme 63011
    France

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    Clermont-Ferrand, Puy-de-Dôme 63011
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    Villejuif, Val-de-Marne 94800
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    Villejuif, Val-de-Marne 94800
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  • Groupe hospitalier Paris saint Joseph

    Paris, Île-de-France Region 75014
    France

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    Paris, Île-de-France Region 75014
    France

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    Paris 2988507, Île-de-France Region 3012874 75014
    France

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  • Hôpital Européen Georges Pompidou

    Paris, 75015
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    Paris, 75015
    France

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  • NCT

    Heidelberg, Baden-Wurttemberg 69120
    Germany

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    Nürtingen, Baden-Wurttemberg 72622
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  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg 72622
    Germany

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    Heidelberg 2907911, Baden-Wurttemberg 2953481 69120
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    Munich, Bavaria 81675
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    Nuremberg, Bavaria 90419
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    Regensburg, Bavaria 93053
    Germany

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    Munich 2867714, Bavaria 2951839 81675
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    Regensburg 2849483, Bavaria 2951839 93053
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    Hanover, Lower Saxony 30625
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    Hanover, Lower Saxony 30625
    Germany

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  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein 24105
    Germany

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    Kiel 2891122, Schleswig-Holstein 2838632 24105
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    Jena, Thuringia 07747
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    Jena 2895044, Thuringia 2822542 07747
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    Berlin, 10117
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    Berlin, 10117
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    Düsseldorf, 40225
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    Düsseldorf 2934246, 40225
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    Frankfurt, 60488
    Germany

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    Frankfurt 2925536, 60488
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    Hamburg, 20246
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    Hamburg, 20246
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    Herne, 44625
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    Herne 2905891, 44625
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    Ulm, 89081
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    Ulm 2820256, 89081
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    Cork, T12 DC4A
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    Cork 2965140, T12 E8YV
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    Dublin, D24 NR0A
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    Dublin, D24 NR0A
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    Petah Tikva, Central District 4941492
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    Petah Tikva, Central District 4941492
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    Ẕerifin, Central District 70300
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    Ẕerifin, Central District 70300
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    Jerusalem, Jerusalem 9112001
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    Jerusalem, Jerusalem 9112001
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    Haifa, Northern District 3109601
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    Haifa, Northern District 3109601
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    Bari, Apulia 70124
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    Genoa, Liguria 16132
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    Genoa, Liguria 16132
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    Genoa, Liguria 16132
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    Rome, Roma 00144
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    Pisa, Tuscany 56126
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    Pisa, Tuscany 56126
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    Castelfranco Veneto, Veneto 31033
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    Castelfranco Veneto, Veneto 31033
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    Milan, 20133
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    Milan, 20132
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    Milan 6951411, 20132
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    Naples, 80131
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    Parma, 43126
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    Parma, 43126
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    Kawasaki, Kanagawa 216-8511
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    Bunkyo-ku, Tokyo 1138603
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    Koto-ku, Tokyo 135-8550
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    Toyoma, Toyama 930-0194
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    Breda, North Brabant 4818 CK
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    Amsterdam, North Holland 1066 CX
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    Leeuwarden, Provincie Friesland 8934 AD
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    Lørenskog, Akershus 1478
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    Tønsberg, Vestfold 3103
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    Tønsberg, Vestfold 3103
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    Sarpsborg, Østfold fylke 1714
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    Tønsberg 3134331, 3116
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    Craiova, Dolj 200542
    Romania

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    Cluj-Napoca, 400015
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    Cluj-Napoca, 400015
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    Iași, 700483
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    Iași 675810, 700483
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    Barcelona, Barcelona [Barcelona] 08035
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    Barcelona, Catalunya [Cataluña] 08041
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    Madrid, Madrid, Comunidad de 28034
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    Valencia, Valenciana, Comunitat 46009
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    Valencia, Valenciana, Comunitat 46009
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    Badajoz, 06006
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    Badajoz 2521420, 06006
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    Córdoba, 14004
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    Madrid, 28040
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    Madrid, 28007
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    Madrid, 28041
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    Seville, 41013
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    Solna, Stockholms Län [se-01] 171 64
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    Gothenburg, Västra Götalands Län [se-14] 413 45
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    Gothenburg, Västra Götalands Län [se-14] 413 45
    Sweden

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    Gothenburg 2711537, SE-416 85
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    Malmö, 205 02
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    Bellinzona, Canton Ticino 6500
    Switzerland

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    Switzerland

    Site Not Available

  • Cantonal Hospital St.Gallen

    Sankt Gallen, Canton of St. Gallen 9007
    Switzerland

    Active - Recruiting

  • Local Institution - 0077

    Sankt Gallen 2658822, Canton of St. Gallen 2658821 9007
    Switzerland

    Site Not Available

  • Kantonsspital Graubünden

    Chur, 7000
    Switzerland

    Active - Recruiting

  • Local Institution - 0108

    Chur 2661169, 7000
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich

    Zurich, 8091
    Switzerland

    Active - Recruiting

  • Local Institution - 0148

    Zurich 2657896, 8091
    Switzerland

    Site Not Available

  • Local Institution - 0243

    Glasgow, Glasgow City G12 0YN
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital

    London, London, City of EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital (Sutton)

    London, Sutton SM2 5PT
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital (Sutton)

    London 2643743, Sutton SM2 5PT
    United Kingdom

    Active - Recruiting

  • Local Institution - 0237

    London 2643743, EC1A 7BE
    United Kingdom

    Site Not Available

  • Local Institution - 0230

    Sheffield, S10 2SJ
    United Kingdom

    Site Not Available

  • Local Institution - 0167

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Local Institution - 0162

    Fullerton, California 92835
    United States

    Site Not Available

  • Local Institution - 0252

    Palo Alto, California 94304
    United States

    Site Not Available

  • Palo Alto Center-Palo Alto Medical Foundation Research Institute

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Local Institution - 0139

    Sacramento, California 95817
    United States

    Site Not Available

  • Local Institution - 0163

    Sacramento, California 95816
    United States

    Site Not Available

  • Sutter Health - Sutter Institute for Medical Research

    Sacramento, California 95816
    United States

    Active - Recruiting

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Local Institution - 0251

    San Francisco, California 94115
    United States

    Site Not Available

  • Pacific Hematology Oncology Associates

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Local Institution - 0254

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Sutter Santa Rosa

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Local Institution - 0163

    Sacramento 5389489, California 5332921 95816
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Local Institution - 0245

    Dillon, Colorado 80435
    United States

    Site Not Available

  • Shaw Cancer Center

    Edwards, Colorado 81632
    United States

    Active - Recruiting

  • Local Institution - 0191

    Edwards 5420885, Colorado 5417618 81632
    United States

    Site Not Available

  • Local Institution - 0250

    Washington D.C., District of Columbia 20016
    United States

    Site Not Available

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia 20016
    United States

    Active - Recruiting

  • Local Institution - 0247

    Miami, Florida 33176
    United States

    Site Not Available

  • Local Institution - 0193

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Local Institution - 0232

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Local Institution - 0195

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Local Institution - 0168

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Local Institution - 0248

    Buffalo, New York 14203
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Local Institution - 0161

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The James Outpatient Care West Campus

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • Cleveland Clinic - Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Local Institution - 0192

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Local Institution - 0256

    Cleveland 5150529, Ohio 5165418 44111
    United States

    Site Not Available

  • Local Institution - 0257

    Mayfield Heights 5162188, Ohio 5165418 44124
    United States

    Site Not Available

  • Local Institution - 0141

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0084

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Local Institution - 0186

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Local Institution - 0186

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Local Institution - 0249

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Oncology - West Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Local Institution - 0187

    Austin, Texas 78705
    United States

    Site Not Available

  • Local Institution - 0249

    Abilene 4669635, Texas 4736286 79606-5208
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Local Institution - 0253

    St. George, Utah 84790
    United States

    Site Not Available

  • St George Regional Hospital Cancer Center

    St. George, Utah 84790
    United States

    Active - Recruiting

  • Local Institution - 0111

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Local Institution - 0188

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Local Institution - 0158

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Local Institution - 0200

    Seattle, Washington 98101
    United States

    Site Not Available

  • Local Institution - 0255

    Seattle, Washington 98109
    United States

    Site Not Available

  • Local Institution - 0259

    Seattle, Washington 98195
    United States

    Site Not Available

  • Local Institution - 0200

    Seattle 5809844, Washington 5815135 98101
    United States

    Site Not Available

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