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

Last updated: March 10, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Renal Cell Carcinoma

Kidney Cancer

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:
August 29, 2025

Connect with a study center

  • Local Institution - 0100

    Capital Federal, Buenos Aires 1419
    Argentina

    Site Not Available

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1280
    Argentina

    Site Not Available

  • Local Institution - 0011

    Ciudad Autónoma 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 - 0025

    Rio Cuarto, Cordoba 5800
    Argentina

    Site Not Available

  • Local Institution - 0001

    Viedma, Río Negro R8500ACE
    Argentina

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  • Local Institution

    Buenos Aires, 1417
    Argentina

    Site Not Available

  • Local Institution - 0005

    Cordoba, X5004FHP
    Argentina

    Site Not Available

  • Local Institution - 0002

    San Juan, 5400
    Argentina

    Site Not Available

  • Local Institution - 0033

    Graz, 8036
    Austria

    Site Not Available

  • Local Institution - 0031

    Vienna, 1090
    Austria

    Site Not Available

  • Local Institution - 0032

    Wels, 4600
    Austria

    Site Not Available

  • Local Institution - 0003

    Santiago, Metropolitana 8330024
    Chile

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  • Local Institution - 0034

    Santiago, Metropolitana 8420383
    Chile

    Site Not Available

  • Local Institution

    Santiago de Chile, Metropolitana
    Chile

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  • Local Institution - 0017

    Independencia, Santiago
    Chile

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  • 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 - 0012

    Viña El Mar, Valparaíso 254 0488
    Chile

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  • Local Institution - 0020

    Brno, Jihomoravský Kraj 602 00
    Czechia

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  • Local Institution - 0097

    Brno, 656 53
    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 - 0074

    Brest, Finistère 29609
    France

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  • Local Institution - 0078

    Nancy, Meurthe-et-Moselle 54100
    France

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  • Local Institution - 0091

    Valenciennes, 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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  • Chu Angers

    Angers Cedex 10, 49933
    France

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  • CHRU Jean Minjoz

    Besancon Cedex, 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

    Grenoble, 38043
    France

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  • Local Institution - 0081

    Hyeres, 83400
    France

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  • Local Institution - 0080

    La Tronche, 38043
    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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  • 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 Cedex, 67091
    France

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  • Local Institution - 0072

    Suresnes, 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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  • Local Institution - 0023

    Athens, 15125
    Greece

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    Larissa, 41110
    Greece

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  • Local Institution - 0082

    Brescia, Lombardia 25123
    Italy

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    Arezzo, 52100
    Italy

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    Aviano (PN), 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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    Napoli, 80131
    Italy

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    Parma, 43100
    Italy

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    Roma, 00128
    Italy

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  • 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

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  • Local Institution - 0067

    Monterrey, Nuevo LEON 64040
    Mexico

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  • Local Institution - 0008

    Chihuahua, 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 - 0030

    Biala Podlaska, 21-500
    Poland

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  • Local Institution - 0095

    Bydgoszcz, 85-796
    Poland

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  • Local Institution - 0062

    Bytom, 41-902
    Poland

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    Gdansk, 80-219
    Poland

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    Krakow, 31-115
    Poland

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    Poznan, 61-848
    Poland

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    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

    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 - 0056

    Cluj-Napoca, 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 - 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 - 0042

    Cordoba, 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 - 0045

    Pamplona, 31008
    Spain

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  • Local Institution - 0039

    Sabadell, 08208
    Spain

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  • Local Institution - 0043

    Santander, 39008
    Spain

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  • Local Institution - 0044

    Santiago Compostela, 15706
    Spain

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  • Local Institution - 0041

    Sevilla, 41013
    Spain

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  • Local Institution - 0040

    Valencia, 46009
    Spain

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  • Local Institution

    Stamford, Connecticut 06904
    United States

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  • Local Institution - 0013

    Washington, District of Columbia 20007
    United States

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  • 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

    Chicago, Illinois 60637
    United States

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  • Local Institution - 0066

    Boston, Massachusetts 02114
    United States

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  • Local Institution - 0086

    Boston, Massachusetts 02215
    United States

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  • Local Institution - 0088

    Boston, Massachusetts 02114
    United States

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  • 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

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  • The Reading Hosp Med Ctr Reg Cancer Ctr

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Local Institution - 0084

    Charleston, South Carolina 29414
    United States

    Site Not Available

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