Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01844505
First received: April 29, 2013
Last updated: September 15, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


Condition Intervention Phase
Unresectable or Metastatic Melanoma
Biological: Nivolumab
Biological: Ipilimumab
Biological: Placebo for Nivolumab
Biological: Placebo for Ipilimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Endpoint of Overall Survival (OS) in all randomized subjects [ Time Frame: Approximately up to 44.1 months ] [ Designated as safety issue: No ]
    OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication

  • Progress Free Survival (PFS) [ Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] [ Designated as safety issue: No ]
    PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Baseline (Day 1), Week 12 every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
    ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of randomized subjects for each treatment group. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first

  • Differences in OS, PFS, and ORR between the two experimental arms [ Time Frame: OS: Approximately up to 44.1 months; PFS and OOR: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] [ Designated as safety issue: No ]
  • OS based on PD-L1 expression [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
  • Mean changes from baseline in EORTC-QLQ-C30 [ Time Frame: Day 1 of Week 1, Day 1 of Week 5 and Follow up visits 1 and 2 ] [ Designated as safety issue: No ]
    European Organisation for Research and Treatment of Care Quality of Life Questionnaire (EORTC QLQ) C-30 global health status/QoL composite scale data and the remaining EORTC QLQ C-30 scale data will be summarized by timepoint using descriptive statistics for each treatment group


Estimated Enrollment: 915
Study Start Date: May 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Biological: Placebo for Nivolumab Biological: Placebo for Ipilimumab
Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab
Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010
Biological: Placebo for Nivolumab
Experimental: Arm C: Ipilimumab+Placebo for Nivolumab
Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010
Biological: Placebo for Nivolumab

  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:

  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment naïve patients
  • Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
  • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
  • Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
  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: NCT01844505

  Hide Study Locations
Locations
United States, Arizona
Banner-Md Anderson Cancer Center
Gilbert, Arizona, United States, 85234
University Of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Uc San Diego Moores Cancer Center
La Jolla, California, United States, 92093
The Angeles Clinic And Research Institute.
Los Angeles, California, United States, 90025
University Of California - Los Angeles
Los Angeles, California, United States, 90095
Comprehensive Cancer Center At Desert Regional Medical Ctr
Palm Springs, California, United States, 92262
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
Sutter West Bay Hospitals D/B/A Cal Pacific Medical Center
San Francisco, California, United States, 94115
University Of California At San Francisco
San Francisco, California, United States, 94115
United States, Colorado
University Of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Orlando Health, Inc
Orlando, Florida, United States, 32806
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Maine
Maine Center For Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University Of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Allina Health
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
University Of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School Of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Atlantic Melanoma Center
Morristown, New Jersey, United States, 07962
United States, New Mexico
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
New York Oncology Hematology, Pc
Latham, New York, United States, 12110
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Nyu Clinical Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
St. Luke'S Cancer Center - Anderson Campus
Easton, Pennsylvania, United States, 18045
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology
Dallas, Texas, United States, 75246
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
University Of Washington
Seattle, Washington, United States, 98109
Australia, New South Wales
Local Institution
Coffs Harbour, New South Wales, Australia, 2450
Local Institution
Gateshead, New South Wales, Australia, 2290
Local Institution
Sydney, New South Wales, Australia, 2050
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution
Greenslopes Qld, Queensland, Australia, 4102
Local Institution
Southport, Queensland, Australia, 4215
Local Institution
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Local Institution
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Local Institution
Box Hill, Victoria, Australia, 3128
Local Institution
East Melbourne, Victoria, Australia, 3002
Local Institution
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Local Institution
Perth, Western Australia, Australia, 6009
Australia
Local Institution
North Sydney, Australia, 2060
Austria
Local Institution
Salzburg, Austria, 5020
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Wien, Austria, 1090
Belgium
Local Institution
Brussels, Belgium, 1090
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Bruxelles, Belgium, 1200
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Brazil
Local Institution
Fortaleza, Ceara, Brazil, 60430
Local Institution
Curitba, Parana, Brazil, 80530
Local Institution
Ijui, Rio Grande do Sul, Brazil, 98700
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil, 90035
Local Institution
Sao Paulo, Brazil, 01323
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Bc Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Chum-Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Canada
Chu De Quebec
Quebec, Canada, G1R 2J6
Czech Republic
Local Institution
Brno, Czech Republic, 656 53
Local Institution
Hradec Kralove, Czech Republic, 500 05
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Praha 2, Czech Republic, 128 08
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Praha 8, Czech Republic, 180 81
Denmark
Local Institution
Aarhus C, Denmark, 8000
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Herlev, Denmark, 2730
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Odense, Denmark, 5000
Finland
Local Institution
Helsinki, Finland, 00029
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Tampere, Finland, 33521
France
Local Institution
Boulogne Billancourt, France, 92104
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Marseille Cedex 5, France, 13385
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Nantes Cedex, France, 44093
Local Institution
Paris Cedex 10, France, 75475
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Pierre Benite, France, 69310
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Rennes, France, 35042
Local Institution
Villejuif, France, 94805
Germany
Local Institution
Buxtehude, Germany, 21614
Local Institution
Erfurt, Germany, 99089
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Essen, Germany, 45147
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Kiel, Germany, 24105
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Leipzig, Germany, 04103
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Munich, Germany, 80337
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Tubingen, Germany, 72076
Ireland
Local Institution
Cork, Ireland
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Dublin, Ireland
Local Institution
Dublin, Ireland, 7
Local Institution
Dublin, Ireland, 01
Local Institution
Galway, Ireland
Italy
Local Institution
Genova, Italy, 16132
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Meldola (FC), Italy, 47014
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Milano, Italy, 20133
Local Institution
Milano, Italy, 20141
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Napoli, Italy, 80131
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Padova, Italy, 35128
Local Institution
Siena, Italy, 53100
Netherlands
Local Institution
Amsterdam, Netherlands, 1066 CX
Local Institution
Leiden, Netherlands, 2333 ZA
Local Institution
Nijmegen, Netherlands, 6525 GA
New Zealand
Local Institution
Auckland, New Zealand, 1142
Norway
Local Institution
Oslo, Norway, 0424
Poland
Local Institution
Bydgoszcz, Poland, 85-792
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Gdansk, Poland, 80-952
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Krakow, Poland, 31-115
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Lodz, Poland, 93-513
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Warsaw, Poland, 02-781
Romania
Local Institution
Bucharest, Romania, 030171
Local Institution
Bucharest, Romania, 020122
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Bucharest, Romania, 050098
Local Institution
Lasi, Romania, 700483
Local Institution
Timisoara, Romania, 300167
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Saint Petersburg, Russian Federation, 197758
Local Institution
St.-petersburg, Russian Federation, 191104
Local Institution
Voronezh, Russian Federation, 394000
South Africa
Local Institution
Port Elizabeth, Eastern Cape, South Africa, 6045
Local Institution
Bloemfontaine, Free State, South Africa, 9301
Local Institution
Gezina, Pretoria, Gauteng, South Africa, 0002
Local Institution
Johannesburg, Gauteng, South Africa, 2199
Local Institution
Pretoria, Gauteng, South Africa, 0181
Local Institution
Rondebosch, Western Cape, South Africa, 7700
Spain
Local Institution
Badalona-Barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28046
Local Institution
Madrid, Spain, 28007
Local Institution
Malaga, Spain, 29010
Local Institution
Pamplona-Navarra, Spain, 31192
Sweden
Local Institution
Gothenberg, Sweden, 413 45
Local Institution
Stockholm, Sweden, 171 76
Switzerland
Local Institution
Geneva, Switzerland, 1211
Local Institution
Lausanne, Switzerland, 1011
Local Institution
Zurich, Switzerland, 8091
Turkey
Local Institution
Adana, Turkey, 01120
Local Institution
Antalya, Turkey, 07070
Local Institution
Bornova, Izmir, Turkey, 35100
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Local Institution
Swansea, Carmarthenshire, United Kingdom, SA2 8QA
Local Institution
Glasgow, Dumfries & Galloway, United Kingdom, G12 0YN
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4XB
Local Institution
Northwood, Middlesex, United Kingdom, HA6 2JR
Local Institution
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01844505     History of Changes
Other Study ID Numbers: CA209-067, 2012-005371-13
Study First Received: April 29, 2013
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
New Zealand: Medsafe
Canada: Health Canada
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health
Brazil: Ethics Committee
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Switzerland: Federal Office of Public Health
Switzerland: Swissmedic
France: Agence Nationale de Sécurité du Médicament et des produits de santé
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Finland: Finnish Medicines Agency
Finland: Data Protection Board
Finland: National Advisory Board on Health Care Ethics
Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Institutional Review Board
Sweden: Swedish National Council on Medical Ethics
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Ireland: Irish Medicines Board
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014