A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Last updated: January 12, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Kidney Cancer

Cancer/tumors

Renal Cell Carcinoma

Treatment

Ipilimumab

Sunitinib

Nivolumab

Clinical Study ID

NCT03141177
CA209-9ER
2017-000759-20
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Eligibility Criteria

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com Inclusion Criteria:

  • Histological confirmation of RCC with a clear-cell component, including participantswho may also have sarcomatoid features
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCCStage IV) RCC
  • No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if suchtherapy did not include an agent that targets VEGF or VEGF receptors and if recurrenceoccurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion

Exclusion Criteria:

  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg dailyprednisone equivalent) or other immunosuppressive medications within 14 days ofrandomization
  • Participants who have received a live/attenuated vaccine within 30 days of firsttreatment Other protocol defined inclusion/exclusion criteria could apply

Study Design

Total Participants: 701
Treatment Group(s): 4
Primary Treatment: Ipilimumab
Phase: 3
Study Start date:
August 22, 2017
Estimated Completion Date:
April 17, 2024

Connect with a study center

  • Local Institution - 0046

    Caba, Buenos Aires C1120AAT
    Argentina

    Site Not Available

  • Local Institution - 0048

    Ciudad Autonoma De Buenos Aire, Buenos Aires 1181
    Argentina

    Site Not Available

  • Local Institution

    C?rdoba, Cordoba 5016
    Argentina

    Site Not Available

  • Local Institution

    Córdoba, Cordoba 5016
    Argentina

    Site Not Available

  • Local Institution - 0114

    Viedma, RIO Negro 8500
    Argentina

    Site Not Available

  • Centro Medico San Roque

    San Miguel De Tucuman, Tucuman
    Argentina

    Site Not Available

  • Local Institution - 0046

    Buenos Aires, 1120
    Argentina

    Site Not Available

  • Local Institution - 0138

    Caba, 1426
    Argentina

    Site Not Available

  • Local Institution - 0049

    Cordoba, X5004FHP
    Argentina

    Site Not Available

  • Local Institution - 0050

    Cordoba, 5000
    Argentina

    Site Not Available

  • Local Institution - 0047

    Tucuman, 4000
    Argentina

    Site Not Available

  • St Vincent'S Hospital (Nsw)

    Darlinghurst, Australian Capital Territory 2010
    Australia

    Site Not Available

  • Local Institution - 0002

    North Ryde, New South Wales 0
    Australia

    Site Not Available

  • Local Institution

    Northmead, New South Wales 2152
    Australia

    Site Not Available

  • Local Institution

    Sydney, New South Wales 2139
    Australia

    Site Not Available

  • Local Institution - 0008

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Local Institution - 0009

    Sydney, New South Wales 2139
    Australia

    Site Not Available

  • Local Institution - 0073

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Local Institution

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Local Institution - 0006

    Herston, Queensland 4006
    Australia

    Site Not Available

  • Local Institution - 0001

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Local Institution - 0004

    Elizabeth Vale, South Australia 5112
    Australia

    Site Not Available

  • Local Institution - 0005

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Local Institution - 0007

    Doubleview, Western Australia 6018
    Australia

    Site Not Available

  • Local Institution

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0129

    South Brisbane, 4101
    Australia

    Site Not Available

  • Local Institution - 0057

    Belo Horizonte, Minas Gerais 30130-090
    Brazil

    Site Not Available

  • Local Institution - 0119

    Ijui, RIO Grande DO SUL 98700-000
    Brazil

    Site Not Available

  • Local Institution - 0056

    Porto Alegre, RIO Grande DO SUL 90610-000
    Brazil

    Site Not Available

  • Local Institution - 0060

    Porto Alegre, RIO Grande DO SUL 91350-200
    Brazil

    Site Not Available

  • Local Institution

    S?o Paulo, SAO Paulo 05651-901
    Brazil

    Site Not Available

  • Local Institution

    São Paulo, SAO Paulo 05651-901
    Brazil

    Site Not Available

  • Local Institution - 0058

    Barretos, Sao Paulo 14784-400
    Brazil

    Site Not Available

  • Local Institution - 0066

    Rio De Janeiro, 20231-050
    Brazil

    Site Not Available

  • Local Institution - 0061

    Sao Paulo, 05651901
    Brazil

    Site Not Available

  • Local Institution - 0074

    Sao Paulo, 01323-020
    Brazil

    Site Not Available

  • Local Institution - 0045

    Santiago, Metropolitana 8420383
    Chile

    Site Not Available

  • Bradfordhill

    Recoleta, Santiago De Chile
    Chile

    Site Not Available

  • Local Institution - 0034

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Local Institution - 0033

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Local Institution

    Bordeaux, 33075
    France

    Site Not Available

  • Local Institution

    Caen, 14076
    France

    Site Not Available

  • Local Institution

    Lyon Cedex 08, 69373
    France

    Site Not Available

  • Local Institution

    Marseille Cedex 9, 13273
    France

    Site Not Available

  • Local Institution

    Montpellier Cedex, 34295
    France

    Site Not Available

  • Local Institution

    Nantes, 44200
    France

    Site Not Available

  • Local Institution

    Paris, 75015
    France

    Site Not Available

  • Local Institution

    Strasbourg Cedex, 67091
    France

    Site Not Available

  • Local Institution

    Toulouse, 31100
    France

    Site Not Available

  • Local Institution

    Villejuif, 94805
    France

    Site Not Available

  • Local Institution - 0013

    Aachen, 52074
    Germany

    Site Not Available

  • Local Institution - 0016

    Bonn, 53127
    Germany

    Site Not Available

  • Local Institution - 0117

    Essen, 45136
    Germany

    Site Not Available

  • Local Institution - 0023

    Jena, 07747
    Germany

    Site Not Available

  • Local Institution - 0010

    Muenchen, 81675
    Germany

    Site Not Available

  • Local Institution - 0014

    Nuernberg, 90419
    Germany

    Site Not Available

  • Local Institution - 0011

    Tuebingen, 72076
    Germany

    Site Not Available

  • Local Institution - 0082

    Athens, 11528
    Greece

    Site Not Available

  • Local Institution - 0083

    Thessaloniki, 546 45
    Greece

    Site Not Available

  • Local Institution - 0072

    Haifa, 3109601
    Israel

    Site Not Available

  • Local Institution - 0070

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Local Institution - 0071

    Petah Tikva, 49414
    Israel

    Site Not Available

  • Local Institution - 0069

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Local Institution - 0054

    Arezzo, 52100
    Italy

    Site Not Available

  • Local Institution - 0052

    Milano, 20132
    Italy

    Site Not Available

  • Local Institution - 0055

    Napoli, 80131
    Italy

    Site Not Available

  • Local Institution - 0053

    Padova, Padova
    Italy

    Site Not Available

  • Local Institution - 0051

    Pavia, 27100
    Italy

    Site Not Available

  • Local Institution - 0147

    Pavia, 27100
    Italy

    Site Not Available

  • Local Institution - 0172

    Terni, 05100
    Italy

    Site Not Available

  • Local Institution - 0148

    Akita-shi, Akita 010-8543
    Japan

    Site Not Available

  • Local Institution

    Hirosaki-shi, Aomori 036-8563
    Japan

    Site Not Available

  • Local Institution - 0167

    Chiba-shi, Chiba 260-8717
    Japan

    Site Not Available

  • Local Institution - 0164

    Sapporo, Hokkaido 0608543
    Japan

    Site Not Available

  • Local Institution - 0157

    Sapporo-shi, Hokkaido 0608648
    Japan

    Site Not Available

  • Local Institution

    Kobe, Hyogo 6500017
    Japan

    Site Not Available

  • Local Institution - 0168

    Kobe, Hyogo 6500017
    Japan

    Site Not Available

  • Local Institution - 0159

    Morioka, Iwate 0208505
    Japan

    Site Not Available

  • Local Institution

    Morioka-shi, Iwate 0208505
    Japan

    Site Not Available

  • Local Institution - 0166

    Yokohama, Kanagawa 241-8515
    Japan

    Site Not Available

  • Local Institution - 0171

    Yokohama, Kanagawa 236-0004
    Japan

    Site Not Available

  • Local Institution

    Yokohama-shi, Kanagawa 2360004
    Japan

    Site Not Available

  • Local Institution

    Nagasaki-shi, Nagasaki 8528501
    Japan

    Site Not Available

  • Local Institution - 0150

    Niigata-shi, Niigata 9518520
    Japan

    Site Not Available

  • Local Institution - 0169

    Okayama-shi, Okayama 7008558
    Japan

    Site Not Available

  • Local Institution - 0160

    Osaka-sayama, Osaka 589-8511
    Japan

    Site Not Available

  • Local Institution - 0170

    Osaka-shi, Osaka 5418567
    Japan

    Site Not Available

  • Local Institution

    Osakasayama-shi, Osaka 5898511
    Japan

    Site Not Available

  • Local Institution - 0160

    Osakasayamashi, Osaka 5898511
    Japan

    Site Not Available

  • Local Institution - 0163

    Suita-shi, Osaka 565-0871
    Japan

    Site Not Available

  • Local Institution - 0154

    Osaka, Osaka-shi 545-8586
    Japan

    Site Not Available

  • Local Institution - 0155

    Hidaka-shi, Saitama 3501298
    Japan

    Site Not Available

  • Local Institution

    Tokushima-shi, Tokushima 7708503
    Japan

    Site Not Available

  • Local Institution - 0153

    Tokushima-shi, Tokushima 7708503
    Japan

    Site Not Available

  • Local Institution - 0152

    Adachi-ku, Tokyo 123-8558
    Japan

    Site Not Available

  • Local Institution

    Arakawa-ku, Tokyo 1160011
    Japan

    Site Not Available

  • Local Institution - 0151

    Bunkyo-ku, Tokyo 1138603
    Japan

    Site Not Available

  • Local Institution - 0158

    Bunkyo-ku, Tokyo 1138519
    Japan

    Site Not Available

  • Local Institution - 0173

    Minato-ku, Tokyo 1058470
    Japan

    Site Not Available

  • Local Institution

    Shinjuku-Ku, Tokyo 1608582
    Japan

    Site Not Available

  • Local Institution

    Yamagata-shi, Yamagata 9909585
    Japan

    Site Not Available

  • Local Institution - 0156

    Aomori, 0368563
    Japan

    Site Not Available

  • Local Institution - 0167

    Chiba, 260-8717
    Japan

    Site Not Available

  • Local Institution - 0161

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Local Institution

    Nagasaki, 8528501
    Japan

    Site Not Available

  • Local Institution - 0162

    Nagasaki, 8528501
    Japan

    Site Not Available

  • Local Institution - 0149

    Tokyo, 160-8582
    Japan

    Site Not Available

  • Local Institution - 0165

    Yamagata, 9909585
    Japan

    Site Not Available

  • Local Institution - 0062

    Ciudad de Mexico, Distrito Federal 06100
    Mexico

    Site Not Available

  • Local Institution - 0116

    Mexico, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution - 0115

    Tlalpan, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution

    Zapapan, Jalisco 45030
    Mexico

    Site Not Available

  • Local Institution - 0108

    Zapopan, Jalisco 45070
    Mexico

    Site Not Available

  • Local Institution - 0143

    Monterrey, Nuevo LEON 64060
    Mexico

    Site Not Available

  • Local Institution - 0064

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Local Institution - 0065

    Monterrey, Nuevo Leon 64000
    Mexico

    Site Not Available

  • Local Institution - 0136

    Merida, Yucatan 97125
    Mexico

    Site Not Available

  • Axis Heilsa S de Rl de Cv

    Monterrey, NL, 64060
    Mexico

    Site Not Available

  • Local Institution - 0063

    Queretaro, 76000
    Mexico

    Site Not Available

  • Local Institution - 0084

    Biala Podlaska, 21-500
    Poland

    Site Not Available

  • Local Institution - 0130

    Bydgoszcz, 85796
    Poland

    Site Not Available

  • Local Institution - 0085

    Gdansk, 80-219
    Poland

    Site Not Available

  • Local Institution

    Cluj Napoca, 400015
    Romania

    Site Not Available

  • Local Institution - 0021

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Local Institution - 0022

    Craiova, 200542
    Romania

    Site Not Available

  • Local Institution

    Romania, 400015
    Romania

    Site Not Available

  • Local Institution - 0020

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Local Institution

    Nizhniy Novgorod, 603109
    Russian Federation

    Site Not Available

  • Local Institution - 0099

    Saint-Petersburg, 197758
    Russian Federation

    Site Not Available

  • Local Institution

    A Coru?a, 15006
    Spain

    Site Not Available

  • Local Institution

    A Coruña, 15006
    Spain

    Site Not Available

  • Local Institution - 0125

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution - 0120

    Madrid, 28041
    Spain

    Site Not Available

  • Local Institution - 0121

    Madrid, 28009
    Spain

    Site Not Available

  • Local Institution - 0144

    Santander, 39008
    Spain

    Site Not Available

  • Local Institution - 0124

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution - 0123

    Valencia, 46014
    Spain

    Site Not Available

  • Local Institution - 0094

    Ankara, 06800
    Turkey

    Site Not Available

  • Local Institution - 0107

    Ankara, 06018
    Turkey

    Site Not Available

  • Local Institution - 0139

    Ankara, 06590
    Turkey

    Site Not Available

  • Local Institution - 0096

    Antalya, 07070
    Turkey

    Site Not Available

  • Local Institution - 0097

    Denizli, 20070
    Turkey

    Site Not Available

  • Local Institution - 0095

    Edirne, 22030
    Turkey

    Site Not Available

  • Local Institution

    Edrine, 22010
    Turkey

    Site Not Available

  • Local Institution - 0146

    Istanbul, 34300
    Turkey

    Site Not Available

  • Local Institution - 0111

    London, EC1A 7BE
    United Kingdom

    Site Not Available

  • Local Institution - 0109

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Local Institution

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Local Institution - 0140

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Local Institution - 0077

    Daphne, Alabama 36526
    United States

    Site Not Available

  • Local Institution - 0044

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • Local Institution - 0132

    Tucson, Arizona 85724-5024
    United States

    Site Not Available

  • Local Institution - 0133

    Bakersfield, California 93309
    United States

    Site Not Available

  • Local Institution - 0093

    Los Angeles, California 90404
    United States

    Site Not Available

  • Local Institution - 0090

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Coastal Integrative Cancer Care

    San Luis Obispo, California 93401
    United States

    Site Not Available

  • Local Institution - 0088

    San Luis Obispo, California 93401
    United States

    Site Not Available

  • Central Coast Medical Oncology Corporation

    Santa Maria, California 93454
    United States

    Site Not Available

  • Local Institution - 0103

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Local Institution - 0127

    Athens, Georgia 30607
    United States

    Site Not Available

  • Local Institution - 0086

    Newnan, Georgia 30265
    United States

    Site Not Available

  • Local Institution - 0036

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Local Institution - 0042

    Zion, Illinois 60099
    United States

    Site Not Available

  • Midwestern Regional Medical Center

    Zion, Illinois 60099
    United States

    Site Not Available

  • Local Institution - 0091

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Local Institution - 0087

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Local Institution - 0037

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0113

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University Of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Local Institution - 0106

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Local Institution - 0035

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Local Institution - 0102

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Local Institution - 0040

    Buffalo, New York 14263
    United States

    Site Not Available

  • Local Institution - 0017

    New York, New York 10065
    United States

    Site Not Available

  • Local Institution

    Cincinnati, Ohio 45230
    United States

    Site Not Available

  • Local Institution - 0067

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0135

    Allentown, Pennsylvania 18105
    United States

    Site Not Available

  • Local Institution - 0105

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Local Institution - 0080

    Austin, Texas 78731
    United States

    Site Not Available

  • Local Institution - 0075

    Dallas, Texas 75246
    United States

    Site Not Available

  • Local Institution

    El Paso, Texas 79902
    United States

    Site Not Available

  • Local Institution - 0068

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution

    Midland, Texas 79701
    United States

    Site Not Available

  • Local Institution

    Plano, Texas 75093
    United States

    Site Not Available

  • Local Institution - 0080

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Local Institution - 0078

    Sherman, Texas 75090
    United States

    Site Not Available

  • Texas Cancer Center - Sherman

    Sherman, Texas 75090
    United States

    Site Not Available

  • Local Institution

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Local Institution - 0131

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Local Institution

    Seattle, Washington 98195
    United States

    Site Not Available

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