A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

Last updated: January 20, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Renal Cell Carcinoma

Carcinoma

Cancer/tumors

Treatment

Ipilimumab

Ipilimumab placebo

Nivolumab

Clinical Study ID

NCT03873402
CA209-8Y8
2018-004695-35
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

Eligibility Criteria

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histological confirmation of renal carcinoma with clear cell component includingparticipants who may have sarcomatoid features.

  • Advanced (not amenable to curative surgery or radiation therapy) renal cellcarcinoma (RCC) or metastatic RCC (mRCC).

  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.

  • No prior systemic therapy for RCC

  • Must be intermediate or poor risk as per International Metastatic RCC DatabaseConsortium (IMDC).

Exclusion

Exclusion Criteria:

  • Any active central nervous system (CNS) metastases.

  • Active, known, or suspected autoimmune disease.

  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4antibody, or any other agents specifically targeting T-cell co-stimulation orcheckpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 437
Treatment Group(s): 3
Primary Treatment: Ipilimumab
Phase: 3
Study Start date:
June 21, 2019
Estimated Completion Date:
March 11, 2027

Connect with a study center

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1280
    Argentina

    Site Not Available

  • Local Institution - 0060

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • Local Institution - 0100

    Capital Federal, Buenos Aires 3435907 1419
    Argentina

    Site Not Available

  • Local Institution - 0011

    Ciudad Autónoma de Buenos Aires, Buenos Aires 3435907 1280
    Argentina

    Site Not Available

  • Local Institution - 0060

    Mar del Plata 3430863, Buenos Aires 3435907 7600
    Argentina

    Site Not Available

  • Local Institution - 0025

    Rio Cuarto, Cordoba 5800
    Argentina

    Site Not Available

  • Local Institution - 0025

    Río Cuarto 3838874, Córdoba Province 3860255 5800
    Argentina

    Site Not Available

  • Local Institution - 0001

    Viedma, Río Negro R8500ACE
    Argentina

    Site Not Available

  • Local Institution - 0001

    Viedma 3832899, Río Negro Province 3838830 R8500ACE
    Argentina

    Site Not Available

  • Local Institution

    Buenos Aires, 1417
    Argentina

    Site Not Available

  • Local Institution - 0005

    Cordoba, X5004FHP
    Argentina

    Site Not Available

  • Local Institution - 0005

    Córdoba 3860259, X5004FHP
    Argentina

    Site Not Available

  • Local Institution - 0002

    San Juan, 5400
    Argentina

    Site Not Available

  • Local Institution - 0002

    San Juan 3837213, 5400
    Argentina

    Site Not Available

  • Local Institution - 0033

    Graz, 8036
    Austria

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  • Local Institution - 0033

    Graz 2778067, 8036
    Austria

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  • Local Institution - 0031

    Vienna, 1090
    Austria

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  • Local Institution - 0031

    Vienna 2761369, 1090
    Austria

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  • Local Institution - 0032

    Wels, 4600
    Austria

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  • Local Institution - 0032

    Wels 2761524, 4600
    Austria

    Site Not Available

  • Local Institution - 0003

    Santiago, Metropolitana 8330024
    Chile

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  • Local Institution - 0034

    Santiago, Metropolitana 8420383
    Chile

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  • Local Institution

    Santiago de Chile, Metropolitana
    Chile

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  • Local Institution - 0012

    Viña El Mar, Región de Valparaíso 3868621 254 0488
    Chile

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  • Local Institution - 0004

    Viña del Mar 3868121, Región de Valparaíso 3868621 2520598
    Chile

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  • Local Institution - 0017

    Independencia, Santiago
    Chile

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  • Local Institution - 0017

    Independencia 7114107, Santiago Metropolitan 3873544
    Chile

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  • Local Institution - 0003

    Santiago 3871336, Santiago Metropolitan 3873544 8330024
    Chile

    Site Not Available

  • Local Institution - 0034

    Santiago 3871336, Santiago Metropolitan 3873544 8420383
    Chile

    Site Not Available

  • Local Institution - 0004

    Vina del Mar, Valparaiso 2520598
    Chile

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  • Local Institution - 0012

    Vina del Mar, Valparaiso 2540364
    Chile

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  • Local Institution - 0020

    Brno, Jihomoravský Kraj 602 00
    Czechia

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  • Local Institution - 0020

    Brno 3078610, South Moravian 3339536 602 00
    Czechia

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  • Local Institution - 0097

    Brno, 656 53
    Czechia

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  • Local Institution - 0097

    Brno 3078610, 656 53
    Czechia

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  • Local Institution - 0018

    Prague 3067696, 140 59
    Czechia

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  • Local Institution - 0019

    Prague 3067696, 100 34
    Czechia

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  • Local Institution - 0019

    Praha 10, 100 34
    Czechia

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  • Local Institution - 0018

    Praha 4, 140 59
    Czechia

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  • Local Institution - 0096

    Nice, Alpes-Maritimes 06189
    France

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  • Local Institution - 0096

    Nice 2990440, Alpes-Maritimes 06189
    France

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  • Local Institution - 0074

    Brest, Finistère 29609
    France

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  • Local Institution - 0074

    Brest 3030300, Finistère 29609
    France

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  • Local Institution - 0078

    Nancy, Meurthe-et-Moselle 54100
    France

    Site Not Available

  • Local Institution - 0078

    Nancy 2990999, Meurthe-et-Moselle 54100
    France

    Site Not Available

  • Local Institution - 0091

    Valenciennes, Nord 59300
    France

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  • Local Institution - 0091

    Valenciennes 2971041, Nord 59300
    France

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  • Local Institution - 0073

    ANGERS Cedex 2, 49055
    France

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  • Local Institution - 0069

    Angers, 49100
    France

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  • Local Institution - 0069

    Angers 3037656, 49100
    France

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  • Local Institution - 0073

    Angers 3037656, 49055
    France

    Site Not Available

  • Chu Angers

    Angers Cedex 10, 49933
    France

    Site Not Available

  • CHRU Jean Minjoz

    Besancon Cedex, 25030
    France

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  • Local Institution - 0075

    Besançon 3033123, 25030
    France

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  • Local Institution - 0075

    Besançon Cedex, 25030
    France

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  • Local Institution - 0094

    Caen, 14076
    France

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  • Local Institution - 0094

    Caen 3029241, 14076
    France

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  • Local Institution

    Grenoble, 38043
    France

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  • Local Institution - 0081

    Hyeres, 83400
    France

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  • Local Institution - 0081

    Hyères 3012937, 83400
    France

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  • Local Institution - 0080

    La Tronche, 38043
    France

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  • Local Institution - 0080

    La Tronche 3006131, 38043
    France

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  • Local Institution - 0071

    Marseille 2995469, 13273
    France

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  • Local Institution - 0071

    Marseille Cedex 9, 13273
    France

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  • Local Institution - 0092

    Paris, 75014
    France

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  • Local Institution - 0092

    Paris 2988507, 75014
    France

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  • Institut De Cancerologie De L Ouest

    Saint Herblain, 44805
    France

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  • Local Institution

    Strasbourg, 67200
    France

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  • Local Institution - 0093

    Strasbourg 2973783, 67091
    France

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    Strasbourg Cedex, 67091
    France

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  • Local Institution - 0072

    Suresnes, 92151
    France

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  • Local Institution - 0072

    Suresnes 2973675, 92151
    France

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  • Local Institution

    Toulouse Cedex 9, 31059
    France

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  • Local Institution - 0068

    Villejuif, 94800
    France

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    Villejuif 2968705, 94800
    France

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  • Local Institution - 0023

    Athens, 15125
    Greece

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  • Local Institution - 0023

    Athens 264371, 15125
    Greece

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  • Local Institution - 0024

    Larissa, 41110
    Greece

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  • Local Institution - 0024

    Larissa 258576, 41110
    Greece

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  • Local Institution - 0082

    Brescia, Lombardia 25123
    Italy

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  • Local Institution - 0082

    Brescia 3181554, Lombardy 3174618 25123
    Italy

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  • Local Institution - 0014

    Arezzo, 52100
    Italy

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  • Local Institution - 0014

    Arezzo 3182884, 52100
    Italy

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  • Local Institution - 0016

    Aviano (PN), 33081
    Italy

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  • Local Institution - 0016

    Aviano (PN) 3182635, 33081
    Italy

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  • Local Institution

    Aviano Pn, 33081
    Italy

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  • Local Institution - 0021

    Milan, 20141
    Italy

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  • Local Institution - 0021

    Milan 3173435, 20141
    Italy

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  • Local Institution

    Napoli, 80131
    Italy

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  • Local Institution - 0015

    Parma, 43100
    Italy

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  • Local Institution - 0015

    Parma 3171457, 43100
    Italy

    Site Not Available

  • Local Institution - 0077

    Roma, 00128
    Italy

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  • Local Institution - 0077

    Roma 8957247, 00128
    Italy

    Site Not Available

  • Local Institution - 0006

    Ciudad de Mexico, Distrito Federal 06100
    Mexico

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  • Local Institution - 0009

    Mexico, Distrito Federal 14080
    Mexico

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  • Local Institution - 0010

    Mexico, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution - 0006

    Mexico City 3530597, Mexico City 3527646 06100
    Mexico

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  • Local Institution - 0009

    Mexico City 3530597, Mexico City 3527646 14080
    Mexico

    Site Not Available

  • Local Institution - 0010

    Mexico City 3530597, Mexico City 3527646 14080
    Mexico

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  • Local Institution - 0067

    Monterrey, Nuevo LEON 64040
    Mexico

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  • Local Institution - 0067

    Monterrey 3995465, Nuevo León 3522542 64040
    Mexico

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  • Local Institution - 0008

    Chihuahua, 31000
    Mexico

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  • Local Institution - 0008

    Chihuahua City 4014338, 31000
    Mexico

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  • Local Institution - 0046

    Queretaro, 76000
    Mexico

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  • Local Institution - 0046

    Querétaro, 76000
    Mexico

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  • Local Institution - 0046

    Querétaro 3816887, 76000
    Mexico

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  • Local Institution - 0030

    Biala Podlaska, 21-500
    Poland

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  • Local Institution - 0030

    Biała Podlaska 776175, 21-500
    Poland

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  • Local Institution - 0095

    Bydgoszcz, 85-796
    Poland

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  • Local Institution - 0095

    Bydgoszcz 3102014, 85-796
    Poland

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  • Local Institution - 0062

    Bytom, 41-902
    Poland

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  • Local Institution - 0062

    Bytom 3101950, 41-902
    Poland

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  • Local Institution - 0026

    Gdansk, 80-219
    Poland

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  • Local Institution - 0026

    Gdansk 3099434, 80-219
    Poland

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  • Local Institution

    Krakow, 31-115
    Poland

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  • Local Institution - 0029

    Poznan, 61-848
    Poland

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  • Local Institution - 0029

    Poznan 3088171, 61-848
    Poland

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  • Local Institution - 0027

    Warsaw 756135, 02-781
    Poland

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  • Local Institution - 0027

    Warszawa, 02-781
    Poland

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  • Local Institution

    Wroclaw, 53-413
    Poland

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  • Local Institution - 0050

    Lisboa, 1649-035
    Portugal

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  • Local Institution - 0050

    Lisbon 2267057, 1649-035
    Portugal

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  • Local Institution

    Loures, 2674-514
    Portugal

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  • Local Institution

    Porto, 4200-072
    Portugal

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  • Local Institution - 0061

    Bucharest, 020122
    Romania

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  • Local Institution - 0061

    Bucharest 683506, 020122
    Romania

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  • Local Institution - 0056

    Cluj-Napoca, 400015
    Romania

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  • Local Institution - 0056

    Cluj-Napoca 681290, 400015
    Romania

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  • Local Institution

    Constanta, 900591
    Romania

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  • Local Institution - 0065

    Craiova, 200542
    Romania

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  • Local Institution - 0065

    Craiova 680332, 200542
    Romania

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  • Local Institution - 0054

    Saint Petersburg 498817, Sankt-Peterburg 536203 194044
    Russia

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  • Local Institution - 0058

    Novosibirsk 1496747, 630099
    Russia

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  • Local Institution - 0054

    Saint Petersburg, Sankt-Peterburg 194044
    Russian Federation

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  • Local Institution - 0058

    Novosibirsk, 630099
    Russian Federation

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  • Local Institution

    Saint-Petersburg, 194044
    Russian Federation

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  • Local Institution - 0037

    Barcelona, 08035
    Spain

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  • Local Institution - 0038

    Barcelona, 08003
    Spain

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  • Local Institution - 0037

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Local Institution - 0038

    Barcelona 3128760, 08003
    Spain

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  • Local Institution - 0042

    Cordoba, 14004
    Spain

    Site Not Available

  • Local Institution - 0042

    Córdoba 2519240, 14004
    Spain

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  • Local Institution - 0035

    Madrid, 28046
    Spain

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  • Local Institution - 0036

    Madrid, 28034
    Spain

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  • Local Institution - 0035

    Madrid 3117735, 28046
    Spain

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  • Local Institution - 0036

    Madrid 3117735, 28034
    Spain

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  • Local Institution - 0045

    Pamplona, 31008
    Spain

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  • Local Institution - 0045

    Pamplona 3114472, 31008
    Spain

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  • Local Institution - 0039

    Sabadell, 08208
    Spain

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  • Local Institution - 0039

    Sabadell 3111199, 08208
    Spain

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  • Local Institution - 0043

    Santander, 39008
    Spain

    Site Not Available

  • Local Institution - 0043

    Santander 3109718, 39008
    Spain

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  • Local Institution - 0044

    Santiago Compostela, 15706
    Spain

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  • Local Institution - 0041

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution - 0041

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Local Institution - 0040

    Valencia, 46009
    Spain

    Site Not Available

  • Local Institution - 0040

    Valencia 2509954, 46009
    Spain

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  • Local Institution

    Stamford, Connecticut 06904
    United States

    Site Not Available

  • Local Institution - 0013

    Washington, District of Columbia 20007
    United States

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  • Local Institution - 0013

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Site Not Available

  • Local Institution

    Orlando, Florida 32803
    United States

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  • Local Institution - 0053

    Athens, Georgia 30607
    United States

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  • Local Institution - 0053

    Athens 4180386, Georgia 4197000 30607
    United States

    Site Not Available

  • Local Institution

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Local Institution - 0066

    Boston, Massachusetts 02114
    United States

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  • Local Institution - 0086

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0088

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Local Institution - 0066

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Local Institution - 0086

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Local Institution - 0088

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Local Institution

    Hackensack, New Jersey 07601
    United States

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  • Local Institution

    Buffalo, New York 14263
    United States

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  • Local Institution

    Lake Success, New York 11042
    United States

    Site Not Available

  • The Reading Hosp Med Ctr Reg Cancer Ctr

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • The Reading Hosp Med Ctr Reg Cancer Ctr

    West Reading 5218867, Pennsylvania 6254927 19611
    United States

    Site Not Available

  • Local Institution - 0084

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Local Institution - 0084

    Charleston 4574324, South Carolina 4597040 29414
    United States

    Site Not Available

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