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New hope for kidney cancer: Two-Drug combo shows promise in phase 3 trial

NCT ID NCT03873402

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of two immunotherapy drugs (nivolumab and ipilimumab) works better than one drug alone (nivolumab) for people with advanced kidney cancer that has not been treated before. About 437 participants with intermediate- or poor-risk disease are involved. The goal is to see if the combo slows cancer growth and improves response rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

437 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • Local Institution - 0001

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Local Institution - 0002

    San Juan, 5400, Argentina

  • Local Institution - 0003

    Santiago, Santiago Metropolitan, 8330024, Chile

  • Local Institution - 0004

    Viña del Mar, Valparaiso, 2520598, Chile

  • Local Institution - 0005

    Córdoba, X5004FHP, Argentina

  • Local Institution - 0006

    Mexico City, Mexico City, 06100, Mexico

  • Local Institution - 0008

    Chihuahua City, 31000, Mexico

  • Local Institution - 0009

    Mexico City, Mexico City, 14080, Mexico

  • Local Institution - 0010

    Mexico City, Mexico City, 14080, Mexico

  • Local Institution - 0011

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

  • Local Institution - 0012

    Viña El Mar, Valparaiso, 254 0488, Chile

  • Local Institution - 0013

    Washington D.C., District of Columbia, 20007, United States

  • Local Institution - 0014

    Arezzo, 52100, Italy

  • Local Institution - 0015

    Parma, 43100, Italy

  • Local Institution - 0016

    Aviano (PN), 33081, Italy

  • Local Institution - 0017

    Independencia, Santiago Metropolitan, Chile

  • Local Institution - 0018

    Prague, 140 59, Czechia

  • Local Institution - 0019

    Prague, 100 34, Czechia

  • Local Institution - 0020

    Brno, South Moravian, 602 00, Czechia

  • Local Institution - 0021

    Milan, 20141, Italy

  • Local Institution - 0023

    Athens, 15125, Greece

  • Local Institution - 0024

    Larissa, 41110, Greece

  • Local Institution - 0025

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Local Institution - 0026

    Gdansk, 80-219, Poland

  • Local Institution - 0027

    Warsaw, 02-781, Poland

  • Local Institution - 0029

    Poznan, 61-848, Poland

  • Local Institution - 0030

    Biała Podlaska, 21-500, Poland

  • Local Institution - 0031

    Vienna, 1090, Austria

  • Local Institution - 0032

    Wels, 4600, Austria

  • Local Institution - 0033

    Graz, 8036, Austria

  • Local Institution - 0034

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0035

    Madrid, 28046, Spain

  • Local Institution - 0036

    Madrid, 28034, Spain

  • Local Institution - 0037

    Barcelona, 08035, Spain

  • Local Institution - 0038

    Barcelona, 08003, Spain

  • Local Institution - 0039

    Sabadell, 08208, Spain

  • Local Institution - 0040

    Valencia, 46009, Spain

  • Local Institution - 0041

    Seville, 41013, Spain

  • Local Institution - 0042

    Córdoba, 14004, Spain

  • Local Institution - 0043

    Santander, 39008, Spain

  • Local Institution - 0044

    Santiago Compostela, 15706, Spain

  • Local Institution - 0045

    Pamplona, 31008, Spain

  • Local Institution - 0046

    Querétaro, 76000, Mexico

  • Local Institution - 0050

    Lisbon, 1649-035, Portugal

  • Local Institution - 0053

    Athens, Georgia, 30607, United States

  • Local Institution - 0054

    Saint Petersburg, Sankt-Peterburg, 194044, Russia

  • Local Institution - 0056

    Cluj-Napoca, 400015, Romania

  • Local Institution - 0058

    Novosibirsk, 630099, Russia

  • Local Institution - 0060

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Local Institution - 0061

    Bucharest, 020122, Romania

  • Local Institution - 0062

    Bytom, 41-902, Poland

  • Local Institution - 0065

    Craiova, 200542, Romania

  • Local Institution - 0066

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0067

    Monterrey, Nuevo León, 64040, Mexico

  • Local Institution - 0068

    Villejuif, 94800, France

  • Local Institution - 0069

    Angers, 49100, France

  • Local Institution - 0071

    Marseille, 13273, France

  • Local Institution - 0072

    Suresnes, 92151, France

  • Local Institution - 0073

    Angers, 49055, France

  • Local Institution - 0074

    Brest, Finistère, 29609, France

  • Local Institution - 0075

    Besançon, 25030, France

  • Local Institution - 0077

    Roma, 00128, Italy

  • Local Institution - 0078

    Nancy, Meurthe-et-Moselle, 54100, France

  • Local Institution - 0080

    La Tronche, 38043, France

  • Local Institution - 0081

    Hyères, 83400, France

  • Local Institution - 0082

    Brescia, Lombardy, 25123, Italy

  • Local Institution - 0084

    Charleston, South Carolina, 29414, United States

  • Local Institution - 0086

    Boston, Massachusetts, 02215, United States

  • Local Institution - 0088

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0091

    Valenciennes, Nord, 59300, France

  • Local Institution - 0092

    Paris, 75014, France

  • Local Institution - 0093

    Strasbourg, 67091, France

  • Local Institution - 0094

    Caen, 14076, France

  • Local Institution - 0095

    Bydgoszcz, 85-796, Poland

  • Local Institution - 0096

    Nice, Alpes-Maritimes, 06189, France

  • Local Institution - 0097

    Brno, 656 53, Czechia

  • Local Institution - 0100

    Capital Federal, Buenos Aires, 1419, Argentina

  • The Reading Hosp Med Ctr Reg Cancer Ctr

    West Reading, Pennsylvania, 19611, United States

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