A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)

May 23, 2025 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

701

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, 1426
        • Local Institution - 0138
      • Cordoba, Argentina, 5000
        • Local Institution - 0050
      • Cordoba, Argentina, X5004FHP
        • Local Institution - 0049
      • Tucuman, Argentina, 4000
        • Local Institution - 0047
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1120AAT
        • Local Institution - 0046
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
        • Local Institution - 0048
    • RIO Negro
      • Viedma, RIO Negro, Argentina, 8500
        • Local Institution - 0114
  • Australia
      • South Brisbane, Australia, 4101
        • Local Institution - 0129
    • New South Wales
      • North Ryde, New South Wales, Australia
        • Local Institution - 0002
      • Sydney, New South Wales, Australia, 2010
        • Local Institution - 0008
      • Sydney, New South Wales, Australia, 2139
        • Local Institution - 0009
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0073
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Local Institution - 0006
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0001
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0004
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0005
    • Western Australia
      • Doubleview, Western Australia, Australia, 6018
        • Local Institution - 0007
  • Brazil
      • Rio De Janeiro, Brazil, 20231-050
        • Local Institution - 0066
      • Sao Paulo, Brazil, 01323-020
        • Local Institution - 0074
      • Sao Paulo, Brazil, 05651901
        • Local Institution - 0061
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0057
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0119
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
        • Local Institution - 0056
      • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
        • Local Institution - 0060
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Local Institution - 0058
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8420383
        • Local Institution - 0045
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Local Institution - 0034
      • Olomouc, Czechia, 779 00
        • Local Institution - 0033
  • Germany
      • Aachen, Germany, 52074
        • Local Institution - 0013
      • Bonn, Germany, 53127
        • Local Institution - 0016
      • Essen, Germany, 45136
        • Local Institution - 0117
      • Jena, Germany, 07747
        • Local Institution - 0023
      • Muenchen, Germany, 81675
        • Local Institution - 0010
      • Nuernberg, Germany, 90419
        • Local Institution - 0014
      • Tuebingen, Germany, 72076
        • Local Institution - 0011
  • Greece
      • Athens, Greece, 115 28
        • Local Institution - 0082
      • Thessaloniki, Greece, 546 45
        • Local Institution - 0083
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 0072
      • Kfar Saba, Israel, 44281
        • Local Institution - 0070
      • Petah Tikva, Israel, 49414
        • Local Institution - 0071
      • Ramat Gan, Israel, 52621
        • Local Institution - 0069
  • Italy
      • Arezzo, Italy, 52100
        • Local Institution - 0054
      • Milano, Italy, 20132
        • Local Institution - 0052
      • Napoli, Italy, 80131
        • Local Institution - 0055
      • Padova, Italy, Padova
        • Local Institution - 0053
      • Pavia, Italy, 27100
        • Local Institution - 0051
      • Pavia, Italy, 27100
        • Local Institution - 0147
      • Terni, Italy, 05100
        • Local Institution - 0172
  • Japan
      • Chiba, Japan, 260-8717
        • Local Institution - 0167
      • Fukuoka, Japan, 812-8582
        • Local Institution - 0161
      • Nagasaki, Japan, 8528501
        • Local Institution - 0162
      • Tokyo, Japan, 160-8582
        • Local Institution - 0149
      • Yamagata, Japan, 9909585
        • Local Institution - 0165
    • Akita
      • Akita-shi, Akita, Japan, 010-8543
        • Local Institution - 0148
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Local Institution - 0156
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608543
        • Local Institution - 0164
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0157
    • Hyogo
      • Kobe, Hyogo, Japan, 6500017
        • Local Institution - 0168
    • Iwate
      • Morioka, Iwate, Japan, 0208505
        • Local Institution - 0159
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Local Institution - 0171
      • Yokohama, Kanagawa, Japan, 241-8515
        • Local Institution - 0166
    • Niigata
      • Niigata-shi, Niigata, Japan, 9518520
        • Local Institution - 0150
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution - 0169
    • Osaka
      • Osaka-shi, Osaka, Japan, 5418567
        • Local Institution - 0170
      • Osakasayamashi, Osaka, Japan, 5898511
        • Local Institution - 0160
      • Suita-shi, Osaka, Japan, 565-0871
        • Local Institution - 0163
    • Osaka-shi
      • Osaka, Osaka-shi, Japan, 545-8586
        • Local Institution - 0154
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution - 0155
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 7708503
        • Local Institution - 0153
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 123-8558
        • Local Institution - 0152
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0151
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Local Institution - 0158
      • Minato-ku, Tokyo, Japan, 105-8470
        • Local Institution - 0173
  • Mexico
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 06100
        • Local Institution - 0062
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution - 0116
      • Tlalpan, Distrito Federal, Mexico, 14080
        • Local Institution - 0115
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0108
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64060
        • Local Institution - 0143
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution - 0064
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Local Institution - 0065
    • Querétaro
      • Santiago de Queretaro, Querétaro, Mexico, 76000
        • Local Institution - 0063
    • Yucatan
      • Merida, Yucatan, Mexico, 97125
        • Local Institution - 0136
  • Poland
      • Biala Podlaska, Poland, 21-500
        • Local Institution - 0084
      • Bydgoszcz, Poland, 85796
        • Local Institution - 0130
      • Gdansk, Poland, 80-219
        • Local Institution - 0085
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0021
      • Craiova, Romania, 200542
        • Local Institution - 0022
  • Russian Federation
      • Moscow, Russian Federation, 125284
        • Local Institution - 0020
      • Saint-Petersburg, Russian Federation, 197758
        • Local Institution - 0099
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0125
      • Madrid, Spain, 28009
        • Local Institution - 0121
      • Madrid, Spain, 28041
        • Local Institution - 0120
      • Santander, Spain, 39008
        • Local Institution - 0144
      • Sevilla, Spain, 41013
        • Local Institution - 0124
      • Valencia, Spain, 46014
        • Local Institution - 0123
  • Turkey
      • Ankara, Turkey, 06018
        • Local Institution - 0107
      • Ankara, Turkey, 06800
        • Local Institution - 0094
      • Ankara, Turkey, 06620
        • Local Institution - 0139
      • Antalya, Turkey, 07070
        • Local Institution - 0096
      • Denizli, Turkey, 20070
        • Local Institution - 0097
      • Edirne, Turkey, 22030
        • Local Institution - 0095
      • Istanbul, Turkey, 34300
        • Local Institution - 0146
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Local Institution - 0111
      • Manchester, United Kingdom, M20 4BX
        • Local Institution - 0109
      • Truro, United Kingdom, TR1 3LJ
        • Local Institution - 0140
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Local Institution - 0077
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Local Institution - 0044
      • Tucson, Arizona, United States, 85724-5024
        • Local Institution - 0132
    • California
      • Bakersfield, California, United States, 93309
        • Local Institution - 0133
      • Los Angeles, California, United States, 90404
        • Local Institution - 0093
      • Redondo Beach, California, United States, 90277
        • Local Institution - 0090
      • San Luis Obispo, California, United States, 93401
        • Local Institution - 0088
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology Corporation
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0103
    • Georgia
      • Athens, Georgia, United States, 30607
        • Local Institution - 0127
      • Newnan, Georgia, United States, 30265
        • Local Institution - 0086
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Local Institution - 0036
      • Zion, Illinois, United States, 60099
        • Local Institution - 0042
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Local Institution - 0091
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Local Institution - 0087
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0113
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0037
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Local Institution - 0106
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0035
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Local Institution - 0102
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0040
      • New York, New York, United States, 10065
        • Local Institution - 0017
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 0067
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0135
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0105
    • Texas
      • Austin, Texas, United States, 78705
        • Local Institution - 0080
      • Dallas, Texas, United States, 75246
        • Local Institution - 0075
      • Houston, Texas, United States, 77030
        • Local Institution - 0068
      • Sherman, Texas, United States, 75090
        • Local Institution - 0078
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Inclusion Criteria:

  • Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC

  • No prior systemic therapy for RCC with the following exception:

    i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion Criteria:

  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
  • Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doublet
Nivolumab and Cabozantinib
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo
Drug: Cabozantinib
Specified dose on specified days
Other Names:
  • Cabometyx
Active Comparator: Monotherapy
Sunitinib
Drug: Sunitinib
Specified dose on specified days.
Other Names:
  • Sutent
Experimental: Triplet

Nivolumab, Ipilimumab, Cabozantinib

*Enrollment to the triplet arm was discontinued by protocol amendment
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization date to death date (Up to 31 months)
Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
From randomization date to death date (Up to 31 months)
Objective Response Rate (ORR)
Time Frame: Up to 31 Months

Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.

Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
Up to 31 Months
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose to 100 days following last dose (Up to 32 Months)
Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
From first dose to 100 days following last dose (Up to 32 Months)
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: From first to dose to 100 days following last dose (Up to 32 months)
Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
From first to dose to 100 days following last dose (Up to 32 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time Frame: From first dose to 30 days following last dose (Up to 30 months)
Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
From first dose to 30 days following last dose (Up to 30 months)
Number of Deaths
Time Frame: From first dose to (up to 31 months) following first dose
Number of deaths due to any cause during the specified time frame.
From first dose to (up to 31 months) following first dose
Number of Participants With Laboratory Abnormalities
Time Frame: From first dose to 30 days following last dose (Up to 30 Months)
Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
From first dose to 30 days following last dose (Up to 30 Months)
Number of Participants With Laboratory Values Grade Shifting From Baseline
Time Frame: From first dose to 30 days following last dose (Up to 30 Months)
Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
From first dose to 30 days following last dose (Up to 30 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd
Exelixis

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2017

Primary Completion (Actual)

February 12, 2020

Study Completion (Estimated)

January 16, 2026

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9ER
  • 2017-000759-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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