A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
NCT ID: NCT03873402
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
437 participants
INTERVENTIONAL
2019-06-21
2027-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nivolumab + ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Nivolumab + ipilimumab placebo
Ipilimumab placebo
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Ipilimumab placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0013
Washington D.C., District of Columbia, United States
Local Institution - 0053
Athens, Georgia, United States
Local Institution - 0066
Boston, Massachusetts, United States
Local Institution - 0088
Boston, Massachusetts, United States
Local Institution - 0086
Boston, Massachusetts, United States
The Reading Hosp Med Ctr Reg Cancer Ctr
West Reading, Pennsylvania, United States
Local Institution - 0084
Charleston, South Carolina, United States
Local Institution - 0100
Capital Federal, Buenos Aires, Argentina
Local Institution - 0011
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0060
Mar del Plata, Buenos Aires, Argentina
Local Institution - 0025
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0001
Viedma, Río Negro Province, Argentina
Local Institution - 0005
Córdoba, , Argentina
Local Institution - 0002
San Juan, , Argentina
Local Institution - 0033
Graz, , Austria
Local Institution - 0031
Vienna, , Austria
Local Institution - 0032
Wels, , Austria
Local Institution - 0004
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0012
Viña El Mar, Región de Valparaíso, Chile
Local Institution - 0017
Independencia, Santiago Metropolitan, Chile
Local Institution - 0003
Santiago, Santiago Metropolitan, Chile
Local Institution - 0034
Santiago, Santiago Metropolitan, Chile
Local Institution - 0020
Brno, South Moravian, Czechia
Local Institution - 0097
Brno, , Czechia
Local Institution - 0019
Prague, , Czechia
Local Institution - 0018
Prague, , Czechia
Local Institution - 0096
Nice, Alpes-Maritimes, France
Local Institution - 0074
Brest, Finistère, France
Local Institution - 0078
Nancy, Meurthe-et-Moselle, France
Local Institution - 0091
Valenciennes, Nord, France
Local Institution - 0073
Angers, , France
Local Institution - 0069
Angers, , France
Local Institution - 0075
Besançon, , France
Local Institution - 0094
Caen, , France
Local Institution - 0081
Hyères, , France
Local Institution - 0080
La Tronche, , France
Local Institution - 0071
Marseille, , France
Local Institution - 0092
Paris, , France
Local Institution - 0093
Strasbourg, , France
Local Institution - 0072
Suresnes, , France
Local Institution - 0068
Villejuif, , France
Local Institution - 0023
Athens, , Greece
Local Institution - 0024
Larissa, , Greece
Local Institution - 0082
Brescia, Lombardy, Italy
Local Institution - 0014
Arezzo, , Italy
Local Institution - 0016
Aviano (PN), , Italy
Local Institution - 0021
Milan, , Italy
Local Institution - 0015
Parma, , Italy
Local Institution - 0077
Roma, , Italy
Local Institution - 0006
Mexico City, Mexico City, Mexico
Local Institution - 0009
Mexico City, Mexico City, Mexico
Local Institution - 0010
Mexico City, Mexico City, Mexico
Local Institution - 0067
Monterrey, Nuevo León, Mexico
Local Institution - 0008
Chihuahua City, , Mexico
Local Institution - 0046
Querétaro, , Mexico
Local Institution - 0030
Biała Podlaska, , Poland
Local Institution - 0095
Bydgoszcz, , Poland
Local Institution - 0062
Bytom, , Poland
Local Institution - 0026
Gdansk, , Poland
Local Institution - 0029
Poznan, , Poland
Local Institution - 0027
Warsaw, , Poland
Local Institution - 0050
Lisbon, , Portugal
Local Institution - 0061
Bucharest, , Romania
Local Institution - 0056
Cluj-Napoca, , Romania
Local Institution - 0065
Craiova, , Romania
Local Institution - 0054
Saint Petersburg, Sankt-Peterburg, Russia
Local Institution - 0058
Novosibirsk, , Russia
Local Institution - 0038
Barcelona, , Spain
Local Institution - 0037
Barcelona, , Spain
Local Institution - 0042
Córdoba, , Spain
Local Institution - 0036
Madrid, , Spain
Local Institution - 0035
Madrid, , Spain
Local Institution - 0045
Pamplona, , Spain
Local Institution - 0039
Sabadell, , Spain
Local Institution - 0043
Santander, , Spain
Local Institution - 0044
Santiago Compostela, , Spain
Local Institution - 0041
Seville, , Spain
Local Institution - 0040
Valencia, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-004695-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-8Y8
Identifier Type: -
Identifier Source: org_study_id
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