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

NCT03873402 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CA209-8Y82018-004695-35
• Study Type: interventional
• Target: 437
• Locations: 14 countries
• Sites: 78

Brief 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

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

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

  Up to 34 months

• Objective response rate (ORR) by BICR

  Up to 23 months

Secondary Outcomes (24)

• Overall survival (OS)

  Up to 4 years

• Overall response rate (ORR) by investigator

  Up to 4 years

• Disease control rate (DCR) by investigator

  Up to 4 years

• Duration of response (DoR) by investigator

  Up to 4 years

• Time to objective response (TTR) by investigator

  Up to 4 years

Study Arms (2)

Nivolumab + ipilimumab

EXPERIMENTAL

Biological: Nivolumab; Biological: Ipilimumab

Nivolumab + ipilimumab placebo

EXPERIMENTAL

Other: Ipilimumab placebo

Interventions

Ipilimumab placebo OTHER

Specified dose on specified days

Nivolumab + ipilimumab placebo

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo

Nivolumab + ipilimumab

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: Yervoy

Nivolumab + ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (78)

Local Institution - 0013

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

Location

Local Institution - 0053

Athens, Georgia, 30607, United States

Location

Local Institution - 0066

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0088

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0086

Boston, Massachusetts, 02215, United States

Location

The Reading Hosp Med Ctr Reg Cancer Ctr

West Reading, Pennsylvania, 19611, United States

Location

Local Institution - 0084

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0100

Capital Federal, Buenos Aires, 1419, Argentina

Location

Local Institution - 0011

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

Location

Local Institution - 0060

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Local Institution - 0025

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0001

Viedma, Río Negro Province, R8500ACE, Argentina

Location

Local Institution - 0005

Córdoba, X5004FHP, Argentina

Location

Local Institution - 0002

San Juan, 5400, Argentina

Location

Local Institution - 0033

Graz, 8036, Austria

Location

Local Institution - 0031

Vienna, 1090, Austria

Location

Local Institution - 0032

Wels, 4600, Austria

Location

Local Institution - 0004

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0012

Viña El Mar, Región de Valparaíso, 254 0488, Chile

Location

Local Institution - 0017

Independencia, Santiago Metropolitan, Chile

Location

Local Institution - 0003

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Local Institution - 0034

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0020

Brno, South Moravian, 602 00, Czechia

Location

Local Institution - 0097

Brno, 656 53, Czechia

Location

Local Institution - 0019

Prague, 100 34, Czechia

Location

Local Institution - 0018

Prague, 140 59, Czechia

Location

Local Institution - 0096

Nice, Alpes-Maritimes, 06189, France

Location

Local Institution - 0074

Brest, Finistère, 29609, France

Location

Local Institution - 0078

Nancy, Meurthe-et-Moselle, 54100, France

Location

Local Institution - 0091

Valenciennes, Nord, 59300, France

Location

Local Institution - 0073

Angers, 49055, France

Location

Local Institution - 0069

Angers, 49100, France

Location

Local Institution - 0075

Besançon, 25030, France

Location

Local Institution - 0094

Caen, 14076, France

Location

Local Institution - 0081

Hyères, 83400, France

Location

Local Institution - 0080

La Tronche, 38043, France

Location

Local Institution - 0071

Marseille, 13273, France

Location

Local Institution - 0092

Paris, 75014, France

Location

Local Institution - 0093

Strasbourg, 67091, France

Location

Local Institution - 0072

Suresnes, 92151, France

Location

Local Institution - 0068

Villejuif, 94800, France

Location

Local Institution - 0023

Athens, 15125, Greece

Location

Local Institution - 0024

Larissa, 41110, Greece

Location

Local Institution - 0082

Brescia, Lombardy, 25123, Italy

Location

Local Institution - 0014

Arezzo, 52100, Italy

Location

Local Institution - 0016

Aviano (PN), 33081, Italy

Location

Local Institution - 0021

Milan, 20141, Italy

Location

Local Institution - 0015

Parma, 43100, Italy

Location

Local Institution - 0077

Roma, 00128, Italy

Location

Local Institution - 0006

Mexico City, Mexico City, 06100, Mexico

Location

Local Institution - 0009

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0010

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0067

Monterrey, Nuevo León, 64040, Mexico

Location

Local Institution - 0008

Chihuahua City, 31000, Mexico

Location

Local Institution - 0046

Querétaro, 76000, Mexico

Location

Local Institution - 0030

Biała Podlaska, 21-500, Poland

Location

Local Institution - 0095

Bydgoszcz, 85-796, Poland

Location

Local Institution - 0062

Bytom, 41-902, Poland

Location

Local Institution - 0026

Gdansk, 80-219, Poland

Location

Local Institution - 0029

Poznan, 61-848, Poland

Location

Local Institution - 0027

Warsaw, 02-781, Poland

Location

Local Institution - 0050

Lisbon, 1649-035, Portugal

Location

Local Institution - 0061

Bucharest, 020122, Romania

Location

Local Institution - 0056

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0065

Craiova, 200542, Romania

Location

Local Institution - 0054

Saint Petersburg, Sankt-Peterburg, 194044, Russia

Location

Local Institution - 0058

Novosibirsk, 630099, Russia

Location

Local Institution - 0038

Barcelona, 08003, Spain

Location

Local Institution - 0037

Barcelona, 08035, Spain

Location

Local Institution - 0042

Córdoba, 14004, Spain

Location

Local Institution - 0036

Madrid, 28034, Spain

Location

Local Institution - 0035

Madrid, 28046, Spain

Location

Local Institution - 0045

Pamplona, 31008, Spain

Location

Local Institution - 0039

Sabadell, 08208, Spain

Location

Local Institution - 0043

Santander, 39008, Spain

Location

Local Institution - 0044

Santiago Compostela, 15706, Spain

Location

Local Institution - 0041

Seville, 41013, Spain

Location

Local Institution - 0040

Valencia, 46009, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: June 21, 2019
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 11, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (7); FR (15); IT (6); PL (6); RO (3); RU (2); ES (11); AU (3); GR (2); CZ (4); AR (7); ME (6); CL (5); PT (1)