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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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