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
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
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There are 152 Locations for this study
Fayetteville Arkansas, 72703, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
San Francisco California, 94115, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Maywood Illinois, 60153, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Lebanon New Hampshire, 03756, United States
Buffalo New York, 14263, United States
New York New York, 10065, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19140, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29601, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Richmond Virginia, 23229, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Berazategui Buenos Aires, 1880, Argentina
Capital Federal Buenos Aires, 1431, Argentina
San Miguel De Tucuman Tucuman, 4000, Argentina
Buenos Aires , C1280, Argentina
Buenos Aires , C1426, Argentina
Cordoba , X5006, Argentina
Westmead New South Wales, 2145, Australia
Woodville South South Australia, 5011, Australia
Box Hill Victoria, 3128, Australia
Clayton Victoria, 3168, Australia
Melbourne Victoria, 3000, Australia
Linz , 4020, Austria
Wien , 1090, Austria
Wien , 1130, Austria
Brussels , 1090, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Ijui RIO Grande DO SUL, 98700, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01321, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Moncton New Brunswick, E1C 8, Canada
Halfax Nova Scotia, B3H 2, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2L 4, Canada
Montreal , H3T 1, Canada
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Prague 5 , 150 0, Czechia
Aarhus N , 8200, Denmark
Herlev , 2730, Denmark
Odense , 5000, Denmark
Helsinki , 00029, Finland
Vandoeuvre-lès-Nancy Lorraine, 54519, France
Bordeaux , 33075, France
Bordeaux , 33075, France
Lyon Cedex , 69373, France
Lyon Cedex , 69373, France
Marseille Cedex 9 , 13009, France
Marseille Cedex 9 , 13009, France
Paris , 75908, France
Poitiers , 86000, France
Poitiers , 86000, France
Saint Herblain Cedex , 44805, France
Saint Herblain Cedex , 44805, France
Toulouse Cedex 9 , 31059, France
Toulouse Cedex 9 , 31059, France
Vandoeuvre Les Nancy , 54511, France
Villejuif Cedex , 94805, France
Villejuif Cedex , 94805, France
Aachen , 52074, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45122, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Munich , 81675, Germany
Tuebingen , 72076, Germany
Athens , 12462, Greece
Thessaloniki , 54645, Greece
Tallaght Dublin, DUBLI, Ireland
Dublin , 7, Ireland
Dublin , Dubli, Ireland
Haifa , 31096, Israel
Petah Tikva , 49100, Israel
Ramat-gan , 52621, Israel
Tel Aviv , 64239, Israel
Arezzo , 52100, Italy
Meldola (fc) , 47014, Italy
Milano , 20133, Italy
Rimini , 47900, Italy
Roma , 00144, Italy
Roma , 00152, Italy
Rozzano , 20089, Italy
Siena , 53100, Italy
Terni , 05100, Italy
Akita-shi Akita, 01085, Japan
Chiba-shi Chiba, 26087, Japan
Higashi-ku Fukuoka, 812-8, Japan
Sapporo-city Hokkaido, 06085, Japan
Sapporo-shi Hokkaido, 06086, Japan
Morioka-shi Iwate, 02085, Japan
Yokohama Kanagawa, 23600, Japan
Kyoto-shi Kyoto, 602-8, Japan
Osaka-sayama-shi Osaka, 58985, Japan
Suita Osaka, 56508, Japan
Hamamatsu-shi Shizuoka, 43131, Japan
Tokushima-shi Tokushima, 77085, Japan
Yamagata-shi Yamagata, 99095, Japan
Kobe-city, Hyogo , 650-0, Japan
Kumamoto , 860-8, Japan
Tokyo , 11386, Japan
Tokyo , 11386, Japan
Tokyo , 13585, Japan
Tokyo , 16085, Japan
Tokyo , 16286, Japan
Tokyo , 17386, Japan
Bergen , 5021, Norway
Lorenskog , 1478, Norway
Gdansk , 80-21, Poland
Lodz , 93-51, Poland
Poznan , 60-56, Poland
Rybnik , 44-20, Poland
Warszawa , 00-90, Poland
Wroclaw , 50-55, Poland
Bucharest , 02232, Romania
Craiova , 20038, Romania
Iasi , 70010, Romania
Timisoara , 30016, Romania
Moscow , 11547, Russian Federation
Moscow , 12130, Russian Federation
St Petersburg , 19825, Russian Federation
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Hospitalet De Llobregat , 08907, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Gothenberg , 413 4, Sweden
Solna , 171 6, Sweden
Cambridge Cambridgeshire, CB2 0, United Kingdom
Swansea Carmarthenshire, SA2 8, United Kingdom
Swansea Carmarthenshire, SA2 8, United Kingdom
London Greater London, HA6 2, United Kingdom
London Greater London, SW3 6, United Kingdom
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