Kidney Cancer Clinical Trial

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Summary

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men & women ≥18 years of age
Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
Advanced/metastatic RCC
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
Karnofsky Performance Score ≥70%

Exclusion Criteria:

Any Central Nervous System (CNS) metastases or history of CNS metastases
Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
Any active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Active chronic liver disease
Prior malignancy active within past 3 years, except for locally curable cancers

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

821

Study ID:

NCT01668784

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 152 Locations for this study

See Locations Near You

Local Institution - 0182
Fayetteville Arkansas, 72703, United States
UCSD Moores Cancer Center
La Jolla California, 92093, United States
Local Institution - 0024
Los Angeles California, 90033, United States
University Of Southern California
Los Angeles California, 90033, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Stanford Cancer Institute
Stanford California, 94305, United States
University Of Colorado
Aurora Colorado, 80045, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Local Institution - 0027
Washington District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Winship Cancer Institute.
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Loyola University Chicago
Maywood Illinois, 60153, United States
Indiana University Simon Cancer Center
Indianapolis Indiana, 46202, United States
University Of Iowa Hospitals And Clinics
Iowa City Iowa, 52242, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore Maryland, 21231, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Nassau
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
The Ohio State University
Columbus Ohio, 43210, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Temple University Hospital
Philadelphia Pennsylvania, 19140, United States
Medical University Of South Carolina
Charleston South Carolina, 29425, United States
St Francis Hospital
Greenville South Carolina, 29601, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Ut Southwestern Medical Center
Dallas Texas, 75390, United States
Local Institution - 0139
Houston Texas, 77030, United States
CTRC at UTHSC San Antonio
San Antonio Texas, 78229, United States
Local Institution - 0076
Richmond Virginia, 23229, United States
Local Institution - 0009
Seattle Washington, 98109, United States
University Of Washington
Seattle Washington, 98109, United States
COIBA
Berazategui Buenos Aires, 1880, Argentina
Local Institution
Capital Federal Buenos Aires, 1431, Argentina
Centro Para La Atencion Integral Del Paciente Oncologico
San Miguel De Tucuman Tucuman, 4000, Argentina
Local Institution
Buenos Aires , C1280, Argentina
Local Institution
Buenos Aires , C1426, Argentina
Instituto Oncologico De Cordoba
Cordoba , X5006, Argentina
Local Institution - 0095
Westmead New South Wales, 2145, Australia
Local Institution
Woodville South South Australia, 5011, Australia
Local Institution
Box Hill Victoria, 3128, Australia
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Clayton Victoria, 3168, Australia
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Melbourne Victoria, 3000, Australia
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Linz , 4020, Austria
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Wien , 1090, Austria
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Wien , 1130, Austria
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Brussels , 1090, Belgium
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
Local Institution - 0125
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0124
Sao Paulo , 01246, Brazil
Local Institution
Sao Paulo , 01321, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
BC Cancer Agency - Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
Centre D'Oncologie Dr-Leon-Richard
Moncton New Brunswick, E1C 8, Canada
QEII Health Sciences Centre
Halfax Nova Scotia, B3H 2, Canada
Local Institution - 0143
Oshawa Ontario, L1G 2, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Chum, Hopital Notre-Dame
Montreal Quebec, H2L 4, Canada
Local Institution - 0145
Montreal , H3T 1, Canada
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Hradec Kralove , 500 0, Czechia
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Olomouc , 779 0, Czechia
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Prague 5 , 150 0, Czechia
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Aarhus N , 8200, Denmark
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Herlev , 2730, Denmark
Local Institution - 0137
Odense , 5000, Denmark
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Helsinki , 00029, Finland
Local Institution - 0006
Vandoeuvre-lès-Nancy Lorraine, 54519, France
Local Institution - 0008
Bordeaux , 33075, France
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Bordeaux , 33075, France
Local Institution - 0007
Lyon Cedex , 69373, France
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Lyon Cedex , 69373, France
Local Institution - 0004
Marseille Cedex 9 , 13009, France
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Marseille Cedex 9 , 13009, France
Local Institution - 0118
Paris , 75908, France
Local Institution - 0003
Poitiers , 86000, France
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Poitiers , 86000, France
Local Institution - 0005
Saint Herblain Cedex , 44805, France
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Saint Herblain Cedex , 44805, France
Local Institution - 0012
Toulouse Cedex 9 , 31059, France
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Toulouse Cedex 9 , 31059, France
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Vandoeuvre Les Nancy , 54511, France
Local Institution - 0002
Villejuif Cedex , 94805, France
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Villejuif Cedex , 94805, France
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Aachen , 52074, Germany
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Dresden , 01307, Germany
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Erlangen , 91054, Germany
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Essen , 45122, Germany
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Hannover , 30625, Germany
Local Institution - 0126
Heidelberg , 69120, Germany
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Munich , 81675, Germany
Local Institution
Tuebingen , 72076, Germany
Alexandra General Hospital Of Athens
Athens , 12462, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki , 54645, Greece
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Tallaght Dublin, DUBLI, Ireland
Local Institution - 0087
Dublin , 7, Ireland
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Dublin , Dubli, Ireland
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Haifa , 31096, Israel
Local Institution - 0148
Petah Tikva , 49100, Israel
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Ramat-gan , 52621, Israel
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Tel Aviv , 64239, Israel
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Arezzo , 52100, Italy
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Meldola (fc) , 47014, Italy
Local Institution - 0082
Milano , 20133, Italy
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Rimini , 47900, Italy
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Roma , 00144, Italy
Local Institution
Roma , 00152, Italy
Local Institution - 0102
Rozzano , 20089, Italy
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Siena , 53100, Italy
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Terni , 05100, Italy
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Akita-shi Akita, 01085, Japan
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Chiba-shi Chiba, 26087, Japan
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Higashi-ku Fukuoka, 812-8, Japan
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Sapporo-city Hokkaido, 06085, Japan
Local Institution
Sapporo-shi Hokkaido, 06086, Japan
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Morioka-shi Iwate, 02085, Japan
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Yokohama Kanagawa, 23600, Japan
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Kyoto-shi Kyoto, 602-8, Japan
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Osaka-sayama-shi Osaka, 58985, Japan
Local Institution - 0169
Suita Osaka, 56508, Japan
Local Institution - 0167
Hamamatsu-shi Shizuoka, 43131, Japan
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Tokushima-shi Tokushima, 77085, Japan
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Yamagata-shi Yamagata, 99095, Japan
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Kobe-city, Hyogo , 650-0, Japan
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Kumamoto , 860-8, Japan
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Tokyo , 11386, Japan
Local Institution
Tokyo , 11386, Japan
Local Institution
Tokyo , 13585, Japan
Local Institution
Tokyo , 16085, Japan
Local Institution
Tokyo , 16286, Japan
Local Institution
Tokyo , 17386, Japan
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Bergen , 5021, Norway
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Lorenskog , 1478, Norway
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Gdansk , 80-21, Poland
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Lodz , 93-51, Poland
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Poznan , 60-56, Poland
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Rybnik , 44-20, Poland
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Warszawa , 00-90, Poland
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Wroclaw , 50-55, Poland
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Bucharest , 02232, Romania
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Craiova , 20038, Romania
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Iasi , 70010, Romania
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Timisoara , 30016, Romania
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Moscow , 11547, Russian Federation
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Moscow , 12130, Russian Federation
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St Petersburg , 19825, Russian Federation
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Pamplona Navarra, 31008, Spain
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Barcelona , 08035, Spain
Local Institution - 0064
Hospitalet De Llobregat , 08907, Spain
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Madrid , 28007, Spain
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Madrid , 28040, Spain
Local Institution
Madrid , 28041, Spain
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Gothenberg , 413 4, Sweden
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Solna , 171 6, Sweden
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Cambridge Cambridgeshire, CB2 0, United Kingdom
Local Institution - 0048
Swansea Carmarthenshire, SA2 8, United Kingdom
Local Institution
Swansea Carmarthenshire, SA2 8, United Kingdom
Local Institution
London Greater London, HA6 2, United Kingdom
Local Institution
London Greater London, SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

821

Study ID:

NCT01668784

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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