Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

437

Study ID:

NCT03873402

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 75 Locations for this study

See Locations Near You

Local Institution - 0013
Washington 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
Rio Cuarto Cordoba, 5800, Argentina
Local Institution - 0001
Viedma Río Negro, R8500, Argentina
Local Institution - 0005
Cordoba , X5004, 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 - 0003
Santiago Metropolitana, 83300, Chile
Local Institution - 0034
Santiago Metropolitana, 84203, Chile
Local Institution - 0017
Independencia Santiago, , Chile
Local Institution - 0004
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0012
Vina del Mar Valparaiso, 25403, Chile
Local Institution - 0020
Brno Jihomoravský Kraj, 602 0, Czechia
Local Institution - 0097
Brno , 656 5, Czechia
Local Institution - 0019
Praha 10 , 100 3, Czechia
Local Institution - 0018
Praha 4 , 140 5, Czechia
Local Institution - 0096
Nice Alpes-Maritimes, 06189, France
Local Institution - 0078
Nancy Meurthe-et-Moselle, 54100, France
Local Institution - 0091
Valenciennes Nord, 59300, France
Local Institution - 0073
ANGERS Cedex 2 , 49055, France
Local Institution - 0069
Angers , 49100, France
Local Institution - 0075
Besançon Cedex , 25030, France
Local Institution - 0074
Brest , 29200, France
Local Institution - 0094
Caen , 14076, France
Local Institution - 0081
Hyeres , 83400, France
Local Institution - 0080
La Tronche , 38043, France
Local Institution - 0071
Marseille Cedex 9 , 13273, France
Local Institution - 0092
Paris , 75014, France
Local Institution - 0093
Strasbourg Cedex , 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 Lombardia, 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
Ciudad de Mexico Distrito Federal, 06100, Mexico
Local Institution - 0009
Mexico Distrito Federal, 14080, Mexico
Local Institution - 0010
Mexico Distrito Federal, 14080, Mexico
Local Institution - 0067
Monterrey Nuevo LEON, 64040, Mexico
Local Institution - 0008
Chihuahua , 31000, Mexico
Local Institution - 0046
Querétaro , 76000, Mexico
Local Institution - 0030
Biala Podlaska , 21-50, Poland
Local Institution - 0095
Bydgoszcz , 85-79, Poland
Local Institution - 0062
Bytom , 41-90, Poland
Local Institution - 0026
Gdansk , 80-21, Poland
Local Institution - 0029
Poznan , 61-84, Poland
Local Institution - 0027
Warszawa , 02-78, Poland
Local Institution - 0050
Lisboa , 1649-, Portugal
Local Institution - 0061
Bucharest , 02012, Romania
Local Institution - 0056
Cluj-Napoca , 40001, Romania
Local Institution - 0065
Craiova , 20054, Romania
Local Institution - 0054
Saint Petersburg Sankt-Peterburg, 19500, Russian Federation
Local Institution - 0058
Novosibirsk , 63009, Russian Federation
Local Institution - 0038
Barcelona , 08003, Spain
Local Institution - 0037
Barcelona , 08035, Spain
Local Institution - 0042
Cordoba , 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
Sevilla , 41013, Spain
Local Institution - 0040
Valencia , 46009, Spain

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

437

Study ID:

NCT03873402

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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