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

This study is ongoing, but not recruiting participants.
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: August 16, 2012
Last updated: January 26, 2016
Last verified: August 2015
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

Condition Intervention Phase
Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
Biological: Nivolumab
Drug: Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Every clinic visit (every 2-4 weeks) up to 42 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Disease assessments every 8 weeks after randomization for every 12 months then 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Disease assessments every 8 weeks after randomization for every 12 months then 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: Disease assessments every 8 weeks after randomization for every 12 months then 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Duration of overall survival (OS) in Programmed death-ligand 1 (PD-L1) positive vs negative subgroups [ Time Frame: At every clinic visit (every 2-4 weeks) while on treatment and then every 3 months ] [ Designated as safety issue: No ]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Continuously throughout study treatment and up to 100 days from last dose ] [ Designated as safety issue: Yes ]
  • Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 100 days from last dose ] [ Designated as safety issue: Yes ]
  • Disease related symptom progression rate [ Time Frame: Baseline, Day 1 of each cycle (starting with cycle 2), then at first 2 follow-up visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 822
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: Nivolumab
Other Name: BMS-936558
Active Comparator: 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
Drug: Everolimus
Other Name: Afinitor


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01668784

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United States, Arkansas
Highland Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Ucsd Moores Cancer Center
La Jolla, California, United States, 92093
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Loyola University Chicago
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
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The Ohio State University
Columbus, Ohio, United States, 43210
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
St Francis Hospital
Greenville, South Carolina, United States, 29601
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Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
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Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
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Berazategui, Buenos Aires, Argentina, 1880
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Capital Federal, Buenos Aires, Argentina, 1425
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San Miguel De Tucuman, Tucuman, Argentina, 4000
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Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
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Bc Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
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Centre D'Oncologie Dr-Leon-Richard
Moncton, New Brunswick, Canada, E1C 8X3
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Qeii Health Sciences Centre
Halfax, Nova Scotia, Canada, B3H 2Y9
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Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
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Chum, Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Smbd Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
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Hradec Kralove, Czech Republic, 500 05
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Prague 5, Czech Republic, 150 06
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Herlev, Denmark, 2730
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Odense C, Denmark, 5000
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Arezzo, Italy, 52100
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Rimini, Italy, 47900
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Roma, Italy, 00144
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Roma, Italy, 00152
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Rozzano, Italy, 20089
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Akita-shi, Akita, Japan, 0108543
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Higashi-ku, Fukuoka, Japan, 812-8582
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Morioka-shi, Iwate, Japan, 0208505
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Yokohama, Kangawa, Japan, 2360004
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Tokyo, Japan, 1358550
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Tokyo, Japan, 1738606
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Bergen, Norway, 5021
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Lorenskog, Norway, 1478
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Gdansk, Poland, 80-219
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Lodz, Poland, 93-513
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Poznan, Poland, 60-569
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Rybnik, Poland, 44-200
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Warszawa, Poland, 00-909
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Wroclaw, Poland, 50-556
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Bucharest, Romania, 022328
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Craiova, Romania, 200385
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Iasi, Romania, 700106
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Timisoara, Romania, 300167
Russian Federation
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 115 478
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St Petersburg, Russian Federation, 198255
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Hospitalet De Llobregat, Barcelona, Spain, 08907
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Pamplona, Navarra, Spain, 31008
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Barcelona, Spain, 08035
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Madrid, Spain, 28041
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Madrid, Spain, 28040
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Madrid, Spain, 28007
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Gothenberg, Sweden, 413 45
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Solna, Sweden, 17176
United Kingdom
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
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Swansea, Carmarthenshire, United Kingdom, SA2 8QA
Local Institution
London, Greater London, United Kingdom, HA6 2RN
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT01668784     History of Changes
Other Study ID Numbers: CA209-025  2011‐005132‐26 
Study First Received: August 16, 2012
Last Updated: January 26, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Data Protection Authority
Norway: Directorate of Health
Poland: National Institute of Medicines
Portugal: National Pharmacy and Medicines Institute
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 07, 2016