Active, not recruitingNCT03873402Updated Jan 21, 2026

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

A Phase 3 interventional study of Nivolumab and Ipilimumab in Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb. Active, not recruiting at 78 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 437
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Conditions studied

Renal Cell Carcinoma

Browse trials for

Carcinoma, Renal Cell 1,965

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 437 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

Inclusion criteria

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 437 participants (actual)

Study arms

Experimental
Nivolumab + ipilimumab
Biological: Nivolumab · Biological: Ipilimumab
Experimental
Nivolumab + ipilimumab placebo
Other: Ipilimumab placebo

Interventions

BiologicalNivolumab
Specified dose on specified days
Also known as: Opdivo
BiologicalIpilimumab
Specified dose on specified days
Also known as: Yervoy
OtherIpilimumab placebo
Specified dose on specified days

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

78 sites

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

References and documents

Individual participant data

Plan to share: Yes — 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03873402
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Mar 13, 2019
Start date: Jun 21, 2019
Primary completion: Mar 11, 2027 (estimated)
Completion: Mar 11, 2027 (estimated)
Last update: Jan 21, 2026

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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