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

January 20, 2026 updated by: Bristol-Myers Squibb

A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

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
      • Córdoba, Argentina, X5004FHP
        • Local Institution - 0005
      • San Juan, Argentina, 5400
        • Local Institution - 0002
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1419
        • Local Institution - 0100
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Local Institution - 0011
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Local Institution - 0060
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0025
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Local Institution - 0001
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0033
      • Vienna, Austria, 1090
        • Local Institution - 0031
      • Wels, Austria, 4600
        • Local Institution - 0032
  • Chile
    • Región de Valparaíso
      • Viña El Mar, Región de Valparaíso, Chile, 254 0488
        • Local Institution - 0012
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • Local Institution - 0004
    • Santiago Metropolitan
      • Independencia, Santiago Metropolitan, Chile
        • Local Institution - 0017
      • Santiago, Santiago Metropolitan, Chile, 8330024
        • Local Institution - 0003
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0034
  • Czechia
      • Brno, Czechia, 656 53
        • Local Institution - 0097
      • Prague, Czechia, 100 34
        • Local Institution - 0019
      • Prague, Czechia, 140 59
        • Local Institution - 0018
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Local Institution - 0020
  • France
      • Angers, France, 49100
        • Local Institution - 0069
      • Angers, France, 49055
        • Local Institution - 0073
      • Besançon, France, 25030
        • Local Institution - 0075
      • Caen, France, 14076
        • Local Institution - 0094
      • Hyères, France, 83400
        • Local Institution - 0081
      • La Tronche, France, 38043
        • Local Institution - 0080
      • Marseille, France, 13273
        • Local Institution - 0071
      • Paris, France, 75014
        • Local Institution - 0092
      • Strasbourg, France, 67091
        • Local Institution - 0093
      • Suresnes, France, 92151
        • Local Institution - 0072
      • Villejuif, France, 94800
        • Local Institution - 0068
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Local Institution - 0096
    • Finistère
      • Brest, Finistère, France, 29609
        • Local Institution - 0074
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54100
        • Local Institution - 0078
    • Nord
      • Valenciennes, Nord, France, 59300
        • Local Institution - 0091
  • Greece
      • Athens, Greece, 15125
        • Local Institution - 0023
      • Larissa, Greece, 41110
        • Local Institution - 0024
  • Italy
      • Arezzo, Italy, 52100
        • Local Institution - 0014
      • Aviano (PN), Italy, 33081
        • Local Institution - 0016
      • Milan, Italy, 20141
        • Local Institution - 0021
      • Parma, Italy, 43100
        • Local Institution - 0015
      • Roma, Italy, 00128
        • Local Institution - 0077
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Local Institution - 0082
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Local Institution - 0008
      • Querétaro, Mexico, 76000
        • Local Institution - 0046
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06100
        • Local Institution - 0006
      • Mexico City, Mexico City, Mexico, 14080
        • Local Institution - 0009
      • Mexico City, Mexico City, Mexico, 14080
        • Local Institution - 0010
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64040
        • Local Institution - 0067
  • Poland
      • Biała Podlaska, Poland, 21-500
        • Local Institution - 0030
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0095
      • Bytom, Poland, 41-902
        • Local Institution - 0062
      • Gdansk, Poland, 80-219
        • Local Institution - 0026
      • Poznan, Poland, 61-848
        • Local Institution - 0029
      • Warsaw, Poland, 02-781
        • Local Institution - 0027
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Local Institution - 0050
  • Romania
      • Bucharest, Romania, 020122
        • Local Institution - 0061
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0056
      • Craiova, Romania, 200542
        • Local Institution - 0065
  • Russia
      • Novosibirsk, Russia, 630099
        • Local Institution - 0058
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 194044
        • Local Institution - 0054
  • Spain
      • Barcelona, Spain, 08003
        • Local Institution - 0038
      • Barcelona, Spain, 08035
        • Local Institution - 0037
      • Córdoba, Spain, 14004
        • Local Institution - 0042
      • Madrid, Spain, 28034
        • Local Institution - 0036
      • Madrid, Spain, 28046
        • Local Institution - 0035
      • Pamplona, Spain, 31008
        • Local Institution - 0045
      • Sabadell, Spain, 08208
        • Local Institution - 0039
      • Santander, Spain, 39008
        • Local Institution - 0043
      • Santiago Compostela, Spain, 15706
        • Local Institution - 0044
      • Seville, Spain, 41013
        • Local Institution - 0041
      • Valencia, Spain, 46009
        • Local Institution - 0040
  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Local Institution - 0013
    • Georgia
      • Athens, Georgia, United States, 30607
        • Local Institution - 0053
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0066
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0088
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0086
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • The Reading Hosp Med Ctr Reg Cancer Ctr
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Local Institution - 0084

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

18 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 renal carcinoma with clear cell component including participants who may have sarcomatoid features.
  • Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (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 Database Consortium (IMDC).

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-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab + ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Experimental: Nivolumab + ipilimumab placebo
Other: Ipilimumab placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) by blinded independent central review (BICR)
Time Frame: Up to 34 months
Up to 34 months
Objective response rate (ORR) by BICR
Time Frame: Up to 23 months
Up to 23 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 4 years
Up to 4 years
Overall response rate (ORR) by investigator
Time Frame: Up to 4 years
Up to 4 years
Disease control rate (DCR) by investigator
Time Frame: Up to 4 years
Up to 4 years
Duration of response (DoR) by investigator
Time Frame: Up to 4 years
Up to 4 years
Time to objective response (TTR) by investigator
Time Frame: Up to 4 years
Up to 4 years
Progression Free Survival (PFS) by investigator
Time Frame: Up to 4 years
Up to 4 years
Progression free survival secondary objective (PFS2) by investigator
Time Frame: Up to 4 years
Up to 4 years
Disease control rate (DCR) by BICR
Time Frame: Up to 4 years
Up to 4 years
Duration of response (DoR) by BICR
Time Frame: Up to 4 years
Up to 4 years
Time to objective response (TTR) by BICR
Time Frame: Up to 4 years
Up to 4 years
Incidence of Adverse Events (AEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of drug-related AEs
Time Frame: Up to 4 years
Up to 4 years
Incidence of Severe Adverse Events (SAEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of drug-related SAEs
Time Frame: Up to 4 years
Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 4 years
Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Time Frame: Up to 4 years
Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: Up to 4 years
Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Serology tests
Time Frame: Up to 4 years
Up to 4 years
PFS based on gene expression (GEP) signatures
Time Frame: Up to 4 years
Up to 4 years
Objective response rate (ORR) based on GEP signatures
Time Frame: Up to 4 years
Up to 4 years
OS based on GEP signatures
Time Frame: Up to 4 years
Up to 4 years
OS based on programmed cell death protein ligand-1 (PD-L1) expression
Time Frame: Up to 4 years
Up to 4 years
ORR by BICR based on PD-L1 expression
Time Frame: Up to 4 years
Up to 4 years
PFS by BICR based on PD-L1 expression
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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.

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)

June 21, 2019

Primary Completion (Estimated)

March 11, 2027

Study Completion (Estimated)

March 11, 2027

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8Y8
  • 2018-004695-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

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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