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.
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
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There are 75 Locations for this study
Washington District of Columbia, 20007, United States
Athens Georgia, 30607, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
West Reading Pennsylvania, 19611, United States
Charleston South Carolina, 29414, United States
Capital Federal Buenos Aires, 1419, Argentina
Ciudad Autónoma de Buenos Aires Buenos Aires, 1280, Argentina
Mar del Plata Buenos Aires, 7600, Argentina
Rio Cuarto Cordoba, 5800, Argentina
Viedma Río Negro, R8500, Argentina
Cordoba , X5004, Argentina
San Juan , 5400, Argentina
Graz , 8036, Austria
Vienna , 1090, Austria
Wels , 4600, Austria
Santiago Metropolitana, 83300, Chile
Santiago Metropolitana, 84203, Chile
Independencia Santiago, , Chile
Vina del Mar Valparaiso, 25205, Chile
Vina del Mar Valparaiso, 25403, Chile
Brno Jihomoravský Kraj, 602 0, Czechia
Brno , 656 5, Czechia
Praha 10 , 100 3, Czechia
Praha 4 , 140 5, Czechia
Nice Alpes-Maritimes, 06189, France
Nancy Meurthe-et-Moselle, 54100, France
Valenciennes Nord, 59300, France
ANGERS Cedex 2 , 49055, France
Angers , 49100, France
Besançon Cedex , 25030, France
Brest , 29200, France
Caen , 14076, France
Hyeres , 83400, France
La Tronche , 38043, France
Marseille Cedex 9 , 13273, France
Paris , 75014, France
Strasbourg Cedex , 67091, France
Suresnes , 92151, France
Villejuif , 94800, France
Athens , 15125, Greece
Larissa , 41110, Greece
Brescia Lombardia, 25123, Italy
Arezzo , 52100, Italy
Aviano (PN) , 33081, Italy
Milan , 20141, Italy
Parma , 43100, Italy
Roma , 00128, Italy
Ciudad de Mexico Distrito Federal, 06100, Mexico
Mexico Distrito Federal, 14080, Mexico
Mexico Distrito Federal, 14080, Mexico
Monterrey Nuevo LEON, 64040, Mexico
Chihuahua , 31000, Mexico
Querétaro , 76000, Mexico
Biala Podlaska , 21-50, Poland
Bydgoszcz , 85-79, Poland
Bytom , 41-90, Poland
Gdansk , 80-21, Poland
Poznan , 61-84, Poland
Warszawa , 02-78, Poland
Lisboa , 1649-, Portugal
Bucharest , 02012, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20054, Romania
Saint Petersburg Sankt-Peterburg, 19500, Russian Federation
Novosibirsk , 63009, Russian Federation
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Pamplona , 31008, Spain
Sabadell , 08208, Spain
Santander , 39008, Spain
Santiago Compostela , 15706, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
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