Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01668784
First received: August 16, 2012
Last updated: November 20, 2014
Last verified: April 2014
  Purpose

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 2016
Estimated Primary Completion Date: February 2016 (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

  Eligibility

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668784

  Hide Study Locations
Locations
United States, Arkansas
Highland Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Ucsd Moores Cancer Center
La Jolla, California, United States, 92093
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
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
United States, New Hampshire
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
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
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
United States, Tennessee
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Therapy And Research Center
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
Argentina
Local Institution
Berazategui, Buenos Aires, Argentina, 1880
Local Institution
Capital Federal, Buenos Aires, Argentina, 1431
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
Local Institution
San Miguel De Tucuman, Tucuman, Argentina, 4000
Local Institution
Buenos Aires, Argentina, C1426ANZ
Local Institution
Buenos Aires, Argentina, C1280AEB
Local Institution
Cordoba, Argentina, X5006HBF
Australia, New South Wales
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Local Institution
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Local Institution
Box Hill, Victoria, Australia, 3128
Local Institution
East Bentleigh, Victoria, Australia, 3165
Local Institution
East Melbourne, Victoria, Australia, 3002
Austria
Local Institution
Linz, Austria, 4010
Local Institution
Vienna, Austria, 1090
Local Institution
Wien, Austria, 1130
Belgium
Local Institution
Brussels, Belgium, 1090
Local Institution
Bruxelles, Belgium, 1200
Local Institution
Gent, Belgium, 9000
Local Institution
Leuven, Belgium, 3000
Brazil
Local Institution
Ijui, Rio Grande Do Sul, Brazil, 98700000
Local Institution
Sao Paulo, Brazil, 01246
Local Institution
Sao Paulo, Brazil, 01321
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Bc Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Centre D'Oncologie Dr-Leon-Richard
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
Qeii Health Sciences Centre
Halfax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Chum, Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Smbd Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
Local Institution
Hradec Kralove, Czech Republic, 500 05
Local Institution
Olomouc, Czech Republic, 775 20
Local Institution
Prague 5, Czech Republic, 150 06
Denmark
Local Institution
Aarhus C, Denmark, 8000
Local Institution
Herlev, Denmark, 2730
Local Institution
Odense C, Denmark, 5000
Finland
Local Institution
Helsinki, Finland, 00029
France
Local Institution
Bordeaux, France, 33075
Local Institution
Lyon Cedex, France, 69373
Local Institution
Marseille Cedex 9, France, 13009
Local Institution
Paris, France, 75908
Local Institution
Poitiers, France, 86000
Local Institution
Saint Herblain Cedex, France, 44805
Local Institution
Toulouse, France, 31052
Local Institution
Vandoeuvre Les Nancy, France, 54511
Local Institution
Villejuif Cedex, France, 94805
Germany
Local Institution
Aachen, Germany, 52074
Local Institution
Dresden, Germany, 01307
Local Institution
Erlangen, Germany, 91054
Local Institution
Essen, Germany, 45122
Local Institution
Hannover, Germany, 30625
Local Institution
Heidelberg, Germany, 69120
Local Institution
Munich, Germany, 81675
Local Institution
Tuebingen, Germany, 72076
Greece
Local Institution
Athens, Greece, 115 28
Local Institution
Thessaloniki, Greece, 54645
Ireland
Local Institution
Tallaght, Dublin, Ireland, DUBLIN 24
Local Institution
Dublin, Ireland, Dublin 7
Local Institution
Dublin, Ireland
Israel
Local Institution
Haifa, Israel, 31096
Local Institution
Petah Tikva, Israel, 49100
Local Institution
Ramat-gan, Israel, 52621
Local Institution
Tel Aviv, Israel, 64239
Italy
Local Institution
Arezzo, Italy, 52100
Local Institution
Meldola (fc), Italy, 47014
Local Institution
Milano, Italy, 20133
Local Institution
Rimini, Italy, 47900
Local Institution
Roma, Italy, 00144
Local Institution
Roma, Italy, 00152
Local Institution
Rozzano, Italy, 20089
Local Institution
Siena, Italy, 53100
Local Institution
Terni, Italy, 05100
Japan
Local Institution
Akita-shi, Akita, Japan, 0108543
Local Institution
Chiba-shi, Chiba, Japan, 2608717
Local Institution
Higashi-ku, Fukuoka, Japan, 812-8582
Local Institution
Sapporo-shi, Hokai-do, Japan, 0608543
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Morioka-shi, Iwate, Japan, 0208505
Local Institution
Yokohama, Kangawa, Japan, 2360004
Local Institution
Kumamoto-shi, Kumamoto, Japan, 8608556
Local Institution
Kyoto-shi, Kyoto, Japan, 602-8566
Local Institution
Suita, Osaka, Japan, 5650871
Local Institution
Hamamatsu-shi, Shizuoka, Japan, 4313192
Local Institution
Tokushima-shi, Tokushima, Japan, 7708503
Local Institution
Yamagata-shi, Yamagata, Japan, 9909585
Local Institution
Kobe-city, Japan, 6500017
Local Institution
Osaka, Japan, 589-8511
Local Institution
Tokyo, Japan, 1738606
Local Institution
Tokyo, Japan, 1358550
Local Institution
Tokyo, Japan, 1628666
Local Institution
Tokyo, Japan, 1138603
Local Institution
Tokyo, Japan, 1138655
Local Institution
Tokyo, Japan, 1608582
Norway
Local Institution
Bergen, Norway, 5021
Local Institution
Lorenskog, Norway, 1478
Poland
Local Institution
Gdansk, Poland, 80-219
Local Institution
Lodz, Poland, 93-513
Local Institution
Poznan, Poland, 60-569
Local Institution
Rybnik, Poland, 44-200
Local Institution
Warszawa, Poland, 00-909
Local Institution
Wroclaw, Poland, 50-556
Romania
Local Institution
Bucharest, Romania, 022328
Local Institution
Craiova, Romania, 200385
Local Institution
Iasi, Romania, 700106
Local Institution
Timisoara, Romania, 300167
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 115 478
Local Institution
Obninsk, Russian Federation, 249036
Local Institution
Saint-Petersburg, Russian Federation, 197136
Local Institution
St Petersburg, Russian Federation, 197022
Spain
Local Institution
Hospitalet De Llobregat, Barcelona, Spain, 08907
Local Institution
Pamplona, Navarra, Spain, 31008
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28040
Sweden
Local Institution
Gothenberg, Sweden, 413 45
Local Institution
Solna, Sweden, 17176
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Local Institution
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01668784     History of Changes
Other Study ID Numbers: CA209-025, 2011‐005132‐26
Study First Received: August 16, 2012
Last Updated: November 20, 2014
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
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014