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Renal Cell CarcinomaPhase 3NCT03873402

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

A Phase 3 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 78 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Nivolumab and Ipilimumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
437 participants
Where
78 sitesin 14 countries
Study dates
21 Jun 2019to 11 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

78 sites in 14 countries.

78 sites in 14 countries

France15 sites

  • Local Institution - 0073

    Angers, 49055

  • Local Institution - 0069

    Angers, 49100

  • Local Institution - 0075

    Besançon, 25030

  • Local Institution - 0074

    Brest, Finistère, 29609

  • Local Institution - 0094

    Caen, 14076

  • Local Institution - 0081

    Hyères, 83400

  • Local Institution - 0080

    La Tronche, 38043

  • Local Institution - 0071

    Marseille, 13273

  • Local Institution - 0078

    Nancy, Meurthe-et-Moselle, 54100

  • Local Institution - 0096

    Nice, Alpes-Maritimes, 06189

  • Local Institution - 0092

    Paris, 75014

  • Local Institution - 0093

    Strasbourg, 67091

  • Local Institution - 0072

    Suresnes, 92151

  • Local Institution - 0091

    Valenciennes, Nord, 59300

  • Local Institution - 0068

    Villejuif, 94800

Other trials in France

Spain11 sites

  • Local Institution - 0038

    Barcelona, 08003

  • Local Institution - 0037

    Barcelona, 08035

  • Local Institution - 0042

    Córdoba, 14004

  • Local Institution - 0036

    Madrid, 28034

  • Local Institution - 0035

    Madrid, 28046

  • Local Institution - 0045

    Pamplona, 31008

  • Local Institution - 0039

    Sabadell, 08208

  • Local Institution - 0043

    Santander, 39008

  • Local Institution - 0044

    Santiago Compostela, 15706

  • Local Institution - 0041

    Seville, 41013

  • Local Institution - 0040

    Valencia, 46009

Other trials in Spain

United States7 sites

  • Local Institution - 0053

    Athens, Georgia, 30607

  • Local Institution - 0066

    Boston, Massachusetts, 02114

  • Local Institution - 0088

    Boston, Massachusetts, 02114

  • Local Institution - 0086

    Boston, Massachusetts, 02215

  • Local Institution - 0084

    Charleston, South Carolina, 29414

  • Local Institution - 0013

    Washington D.C., District of Columbia, 20007

  • The Reading Hosp Med Ctr Reg Cancer Ctr

    West Reading, Pennsylvania, 19611

Other trials in United States

Argentina7 sites

  • Local Institution - 0100

    Capital Federal, Buenos Aires, 1419

  • Local Institution - 0011

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280

  • Local Institution - 0005

    Córdoba, X5004FHP

  • Local Institution - 0060

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0025

    Río Cuarto, Córdoba Province, 5800

  • Local Institution - 0002

    San Juan, 5400

  • Local Institution - 0001

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Italy6 sites

  • Local Institution - 0014

    Arezzo, 52100

  • Local Institution - 0016

    Aviano (PN), 33081

  • Local Institution - 0082

    Brescia, Lombardy, 25123

  • Local Institution - 0021

    Milan, 20141

  • Local Institution - 0015

    Parma, 43100

  • Local Institution - 0077

    Roma, 00128

Other trials in Italy

Mexico6 sites

  • Local Institution - 0008

    Chihuahua City, 31000

  • Local Institution - 0006

    Mexico City, Mexico City, 06100

  • Local Institution - 0009

    Mexico City, Mexico City, 14080

  • Local Institution - 0010

    Mexico City, Mexico City, 14080

  • Local Institution - 0067

    Monterrey, Nuevo León, 64040

  • Local Institution - 0046

    Querétaro, 76000

Other trials in Mexico

Poland6 sites

  • Local Institution - 0030

    Biała Podlaska, 21-500

  • Local Institution - 0095

    Bydgoszcz, 85-796

  • Local Institution - 0062

    Bytom, 41-902

  • Local Institution - 0026

    Gdansk, 80-219

  • Local Institution - 0029

    Poznan, 61-848

  • Local Institution - 0027

    Warsaw, 02-781

Other trials in Poland

Chile5 sites

  • Local Institution - 0017

    Independencia, Santiago Metropolitan

  • Local Institution - 0003

    Santiago, Santiago Metropolitan, 8330024

  • Local Institution - 0034

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0004

    Viña del Mar, Valparaiso, 2520598

  • Local Institution - 0012

    Viña El Mar, Valparaiso, 254 0488

Other trials in Chile

Czechia4 sites

  • Local Institution - 0020

    Brno, South Moravian, 602 00

  • Local Institution - 0097

    Brno, 656 53

  • Local Institution - 0019

    Prague, 100 34

  • Local Institution - 0018

    Prague, 140 59

Other trials in Czechia

Austria3 sites

  • Local Institution - 0033

    Graz, 8036

  • Local Institution - 0031

    Vienna, 1090

  • Local Institution - 0032

    Wels, 4600

Other trials in Austria

Romania3 sites

  • Local Institution - 0061

    Bucharest, 020122

  • Local Institution - 0056

    Cluj-Napoca, 400015

  • Local Institution - 0065

    Craiova, 200542

Other trials in Romania

Greece2 sites

  • Local Institution - 0023

    Athens, 15125

  • Local Institution - 0024

    Larissa, 41110

Other trials in Greece

Russia2 sites

  • Local Institution - 0058

    Novosibirsk, 630099

  • Local Institution - 0054

    Saint Petersburg, Sankt-Peterburg, 194044

Other trials in Russia

Portugal1 site

  • Local Institution - 0050

    Lisbon, 1649-035

Other trials in Portugal

About this study

Official title: 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.

Being tested
Nivolumab, Ipilimumab, Ipilimumab placebo
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called Opdivo

    Specified dose on specified days

  • IpilimumabBiological

    Also called Yervoy

    Specified dose on specified days

  • Ipilimumab placeboOther

    Specified dose on specified days

Study groups in NCT03873402
Study groupRoleWhat they receive
Nivolumab + ipilimumabExperimentalNot described
Receives: Biological: Nivolumab; Biological: Ipilimumab
Nivolumab + ipilimumab placeboExperimentalNot described
Receives: Other: Ipilimumab placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) by blinded independent central review (BICR)

    Measured: Up to 34 months

  2. Objective response rate (ORR) by BICR

    Measured: Up to 23 months

Secondary outcomes (24)

  1. Overall survival (OS)

    Measured: Up to 4 years

  2. Overall response rate (ORR) by investigator

    Measured: Up to 4 years

  3. Disease control rate (DCR) by investigator

    Measured: Up to 4 years

  4. Duration of response (DoR) by investigator

    Measured: Up to 4 years

  5. Time to objective response (TTR) by investigator

    Measured: Up to 4 years

  6. Progression Free Survival (PFS) by investigator

    Measured: Up to 4 years

  7. Progression free survival secondary objective (PFS2) by investigator

    Measured: Up to 4 years

  8. Disease control rate (DCR) by BICR

    Measured: Up to 4 years

  9. Duration of response (DoR) by BICR

    Measured: Up to 4 years

  10. Time to objective response (TTR) by BICR

    Measured: Up to 4 years

  11. Incidence of Adverse Events (AEs)

    Measured: Up to 4 years

  12. Incidence of drug-related AEs

    Measured: Up to 4 years

  13. Incidence of Severe Adverse Events (SAEs)

    Measured: Up to 4 years

  14. Incidence of drug-related SAEs

    Measured: Up to 4 years

  15. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Measured: Up to 4 years

  16. Incidence of clinically significant changes in clinical laboratory results: Coagulation tests

    Measured: Up to 4 years

  17. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Measured: Up to 4 years

  18. Incidence of clinically significant changes in clinical laboratory results: Serology tests

    Measured: Up to 4 years

  19. PFS based on gene expression (GEP) signatures

    Measured: Up to 4 years

  20. Objective response rate (ORR) based on GEP signatures

    Measured: Up to 4 years

  21. OS based on GEP signatures

    Measured: Up to 4 years

  22. OS based on programmed cell death protein ligand-1 (PD-L1) expression

    Measured: Up to 4 years

  23. ORR by BICR based on PD-L1 expression

    Measured: Up to 4 years

  24. PFS by BICR based on PD-L1 expression

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2019
  2. Study start21 Jun 2019
  3. Primary completion11 Mar 2027 (estimated)
  4. Study completion11 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03873402
Sponsor's protocol ID
CA209-8Y8
Other IDs
2018-004695-35, 2018
Status last verified
Jan 2026
First submitted
11 Mar 2019
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 78 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in France, Spain, United States, Argentina, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) by blinded independent central review (BICR) (time frame: Up to 34 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03873402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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