Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
NCT ID: NCT01668784
Last Updated: 2022-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
821 participants
INTERVENTIONAL
2012-10-09
2021-07-19
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
NONE
Study Groups
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Arm 1: Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Arm 2: Everolimus
Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Everolimus
Interventions
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Nivolumab
Everolimus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
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 - 0182
Fayetteville, Arkansas, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Local Institution - 0024
Los Angeles, California, United States
University Of Southern California
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Institute
Stanford, California, United States
University Of Colorado
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Local Institution - 0027
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Winship Cancer Institute.
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Loyola University Chicago
Maywood, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
St Francis Hospital
Greenville, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Local Institution - 0139
Houston, Texas, United States
CTRC at UTHSC San Antonio
San Antonio, Texas, United States
Local Institution - 0076
Richmond, Virginia, United States
Local Institution - 0009
Seattle, Washington, United States
University Of Washington
Seattle, Washington, United States
COIBA
Berazategui, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Centro Para La Atencion Integral Del Paciente Oncologico
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Buenos Aires, , Argentina
Instituto Oncologico De Cordoba
Córdoba, , Argentina
Local Institution - 0095
Westmead, New South Wales, Australia
Local Institution
Woodville South, South Australia, Australia
Local Institution
Box Hill, Victoria, Australia
Local Institution
Clayton, Victoria, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Linz, , Austria
Local Institution
Vienna, , Austria
Local Institution
Vienna, , Austria
Local Institution
Brussels, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Ghent, , Belgium
Local Institution
Leuven, , Belgium
Local Institution - 0125
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0124
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Centre D'Oncologie Dr-Leon-Richard
Moncton, New Brunswick, Canada
QEII Health Sciences Centre
Halfax, Nova Scotia, Canada
Local Institution - 0143
Oshawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Chum, Hopital Notre-Dame
Montreal, Quebec, Canada
Local Institution - 0145
Montreal, , Canada
Local Institution
Hradec Králové, , Czechia
Local Institution
Olomouc, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Aarhus N, , Denmark
Local Institution
Herlev, , Denmark
Local Institution - 0137
Odense, , Denmark
Local Institution
Helsinki, , Finland
Local Institution - 0006
Vandœuvre-lès-Nancy, Lorraine, France
Local Institution - 0008
Bordeaux, , France
Local Institution
Bordeaux, , France
Local Institution - 0007
Lyon, , France
Local Institution
Lyon, , France
Local Institution - 0004
Marseille, , France
Local Institution
Marseille, , France
Local Institution - 0118
Paris, , France
Local Institution - 0003
Poitiers, , France
Local Institution
Poitiers, , France
Local Institution - 0005
Saint-Herblain, , France
Local Institution
Saint-Herblain, , France
Local Institution - 0012
Toulouse, , France
Local Institution
Toulouse, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution - 0002
Villejuif, , France
Local Institution
Villejuif, , France
Local Institution
Aachen, , Germany
Local Institution
Dresden, , Germany
Local Institution
Erlangen, , Germany
Local Institution
Essen, , Germany
Local Institution
Hanover, , Germany
Local Institution - 0126
Heidelberg, , Germany
Local Institution
Munich, , Germany
Local Institution
Tübingen, , Germany
Alexandra General Hospital Of Athens
Athens, , Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Local Institution
Tallaght, Dublin, Ireland
Local Institution - 0087
Dublin, , Ireland
Local Institution
Dublin, , Ireland
Local Institution
Haifa, , Israel
Local Institution - 0148
Petah Tikva, , Israel
Local Institution
Ramat Gan, , Israel
Local Institution
Tel Aviv, , Israel
Local Institution
Arezzo, , Italy
Local Institution
Meldola (fc), , Italy
Local Institution - 0082
Milan, , Italy
Local Institution
Rimini, , Italy
Local Institution
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution - 0102
Rozzano, , Italy
Local Institution
Siena, , Italy
Local Institution
Terni, , Italy
Local Institution
Akita, Akita, Japan
Local Institution
Chiba, Chiba, Japan
Local Institution
Higashiku, Fukuoka, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Morioka, Iwate, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Osaka-sayama-shi, Osaka, Japan
Local Institution - 0169
Suita, Osaka, Japan
Local Institution - 0167
Hamamatsu, Shizuoka, Japan
Local Institution
Tokushima, Tokushima, Japan
Local Institution
Yamagata, Yamagata, Japan
Local Institution
Kobe-city, Hyogo, , Japan
Local Institution
Kumamoto, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Bergen, , Norway
Local Institution
Lorenskog, , Norway
Local Institution
Gdansk, , Poland
Local Institution
Lodz, , Poland
Local Institution
Poznan, , Poland
Local Institution
Rybnik, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Wroclaw, , Poland
Local Institution
Bucharest, , Romania
Local Institution
Craiova, , Romania
Local Institution
Iași, , Romania
Local Institution
Timișoara, , Romania
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Pamplona, Navarre, Spain
Local Institution
Barcelona, , Spain
Local Institution - 0064
L'Hospitalet de Llobregat, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Gothenberg, , Sweden
Local Institution
Solna, , Sweden
Local Institution
Cambridge, Cambridgeshire, United Kingdom
Local Institution - 0048
Swansea, Carmarthenshire, United Kingdom
Local Institution
Swansea, Carmarthenshire, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Countries
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References
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Klijn SL, Fenwick E, Kroep S, Johannesen K, Malcolm B, Kurt M, Kiff C, Borrill J. What Did Time Tell Us? A Comparison and Retrospective Validation of Different Survival Extrapolation Methods for Immuno-Oncologic Therapy in Advanced or Metastatic Renal Cell Carcinoma. Pharmacoeconomics. 2021 Mar;39(3):345-356. doi: 10.1007/s40273-020-00989-1. Epub 2021 Jan 11.
Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.
Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ. A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC). Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.
Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.
Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S. Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025. Eur Urol. 2017 Sep;72(3):368-376. doi: 10.1016/j.eururo.2017.03.037. Epub 2017 Apr 12.
Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators. CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma. Eur Urol. 2017 Dec;72(6):962-971. doi: 10.1016/j.eururo.2017.02.010. Epub 2017 Mar 3.
Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6.
Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2011-005132-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-025
Identifier Type: -
Identifier Source: org_study_id
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