Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
NCT ID: NCT01844505
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
945 participants
INTERVENTIONAL
2013-06-11
2024-04-19
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
QUADRUPLE
Study Groups
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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
Nivolumab
Placebo for Nivolumab
Placebo for Ipilimumab
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
Nivolumab
Ipilimumab
Placebo for Nivolumab
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 (Placebo matching with Nivolumab is no longer required)
Ipilimumab
Placebo for Nivolumab
Interventions
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Nivolumab
Ipilimumab
Placebo for Nivolumab
Placebo for Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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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 - 0085
Gilbert, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Local Institution - 0046
La Jolla, California, United States
Local Institution - 0053
Los Angeles, California, United States
Local Institution - 0014
Los Angeles, California, United States
Comprehensive Cancer Center At Desert Regional Medical Ctr
Palm Springs, California, United States
Local Institution - 0066
Rancho Mirage, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
Local Institution - 0049
San Francisco, California, United States
Local Institution - 0052
Aurora, Colorado, United States
Local Institution - 0084
New Haven, Connecticut, United States
Local Institution - 0098
Washington D.C., District of Columbia, United States
Local Institution - 0183
Washington D.C., District of Columbia, United States
Local Institution - 0042
Jacksonville, Florida, United States
Local Institution - 0008
Orlando, Florida, United States
Local Institution - 0051
Atlanta, Georgia, United States
Maine Center For Cancer Medicine
Scarborough, Maine, United States
Local Institution - 0080
Lutherville, Maryland, United States
Local Institution - 0081
Boston, Massachusetts, United States
Local Institution - 0082
Boston, Massachusetts, United States
Local Institution - 0083
Boston, Massachusetts, United States
Local Institution - 0087
Ann Arbor, Michigan, United States
Local Institution - 0187
Minneapolis, Minnesota, United States
Local Institution - 0065
Jackson, Mississippi, United States
Local Institution - 0067
St Louis, Missouri, United States
Local Institution - 0015
Las Vegas, Nevada, United States
Local Institution - 0188
Morristown, New Jersey, United States
Local Institution - 0068
Albuquerque, New Mexico, United States
Local Institution - 0079
Albany, New York, United States
Local Institution - 0174
New York, New York, United States
Local Institution - 0070
New York, New York, United States
Local Institution - 0047
Charlotte, North Carolina, United States
Local Institution - 0048
Durham, North Carolina, United States
Local Institution - 0007
Cleveland, Ohio, United States
Local Institution - 0045
Portland, Oregon, United States
Local Institution - 0061
Allentown, Pennsylvania, United States
Local Institution - 0112
Bethlehem, Pennsylvania, United States
Local Institution - 0069
Pittsburgh, Pennsylvania, United States
Local Institution - 0154
Greenville, South Carolina, United States
Local Institution - 0062
Nashville, Tennessee, United States
Local Institution - 0064
Nashville, Tennessee, United States
Local Institution - 0044
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Local Institution - 0088
Houston, Texas, United States
Local Institution - 0089
Salt Lake City, Utah, United States
Local Institution - 0054
Seattle, Washington, United States
Local Institution - 0017
Camperdown, New South Wales, Australia
Local Institution - 0031
Coffs Harbour, New South Wales, Australia
Local Institution - 0028
Gateshead, New South Wales, Australia
Local Institution - 0023
Macquarie University, New South Wales, Australia
Local Institution - 0138
North Sydney, New South Wales, Australia
Local Institution - 0019
Brisbane, Queensland, Australia
Local Institution - 0022
Southport, Queensland, Australia
Local Institution - 0018
Woolloongabba, Queensland, Australia
Local Institution - 0020
Adelaide, South Australia, Australia
Local Institution - 0025
Kurralta Park, South Australia, Australia
Local Institution - 0024
Box Hill, Victoria, Australia
Local Institution - 0016
Heidelberg, Victoria, Australia
Local Institution - 0026
Melbourne, Victoria, Australia
Local Institution - 0021
Nedlands, Western Australia, Australia
Local Institution - 0148
Salzburg, , Austria
Local Institution - 0145
Vienna, , Austria
Local Institution - 0003
Brussels, , Belgium
Local Institution - 0002
Brussels, , Belgium
Local Institution - 0004
Edegem, , Belgium
Local Institution - 0005
Ghent, , Belgium
Local Institution - 0103
Leuven, , Belgium
Local Institution - 0140
Edmonton, Alberta, Canada
Local Institution - 0165
Vancouver, British Columbia, Canada
Local Institution - 0141
London, Ontario, Canada
Local Institution - 0143
Ottawa, Ontario, Canada
Local Institution - 0166
Toronto, Ontario, Canada
Local Institution - 0139
Montreal, Quebec, Canada
Local Institution - 0142
Québec, Quebec, Canada
Local Institution - 0092
Brno, , Czechia
Local Institution - 0091
Hradec Králové, , Czechia
Local Institution - 0090
Prague, , Czechia
Local Institution - 0167
Prague, , Czechia
Local Institution - 0076
Aarhus, , Denmark
Local Institution - 0078
Herlev, , Denmark
Local Institution - 0077
Odense, , Denmark
Local Institution - 0071
Helsinki, Uusimaa, Finland
Local Institution - 0169
Tampere, , Finland
Local Institution - 0125
Boulogne-Billancourt, , France
Local Institution - 0126
Marseille, , France
Local Institution - 0056
Nantes, , France
Local Institution - 0058
Paris, , France
Local Institution - 0124
Pierre-Bénite, , France
Local Institution - 0127
Rennes, , France
Local Institution
Villejuif, , France
Local Institution - 0162
Buxtehude, , Germany
Local Institution - 0161
Erfurt, , Germany
Local Institution - 0171
Erlangen, , Germany
Local Institution - 0156
Essen, , Germany
Local Institution - 0159
Hanover, , Germany
Local Institution - 0157
Heidelberg, , Germany
Local Institution - 0158
Kiel, , Germany
Local Institution - 0178
Leipzig, , Germany
Local Institution - 0160
München, , Germany
Local Institution - 0134
Tübingen, , Germany
Local Institution - 0035
Dublin, Dublin, Ireland
Local Institution - 0033
Cork, , Ireland
Local Institution - 0168
Dublin, , Ireland
Local Institution - 0036
Dublin, , Ireland
Local Institution - 0034
Dublin, , Ireland
Local Institution - 0032
Galway, , Ireland
Local Institution - 0120
Jerusalem, , Israel
Local Institution - 0121
Tel Litwinsky, , Israel
Local Institution - 0176
Bergamo, , Italy
Local Institution - 0115
Genova, , Italy
Local Institution - 0113
Meldola (FC), , Italy
Local Institution - 0172
Milan, , Italy
Local Institution - 0117
Milan, , Italy
Local Institution - 0114
Napoli, , Italy
Local Institution - 0118
Padua, , Italy
Local Institution - 0177
Roma, , Italy
Local Institution - 0116
Siena, , Italy
Local Institution - 0010
Amsterdam, , Netherlands
Local Institution - 0012
Leiden, , Netherlands
Local Institution - 0013
Nijmegen, , Netherlands
Local Institution - 0029
Auckland, , New Zealand
Local Institution - 0123
Oslo, , Norway
Local Institution - 0109
Gdansk, , Poland
Local Institution - 0133
Krakow, , Poland
Local Institution - 0060
Lodz, , Poland
Local Institution - 0059
Warsaw, , Poland
Local Institution - 0130
Moscow, , Russia
Local Institution - 0132
Saint Petersburg, , Russia
Local Institution - 0128
Saint Petersburg, , Russia
Local Institution - 0131
Samara, , Russia
Local Institution - 0152
Badalona-Barcelona, , Spain
Local Institution - 0151
Barcelona, , Spain
Local Institution - 0175
Barcelona, , Spain
Local Institution - 0150
Madrid, , Spain
Local Institution - 0149
Madrid, , Spain
Local Institution - 0153
Málaga, , Spain
Local Institution - 0147
Pamplona, , Spain
Local Institution - 0182
Gothenberg, , Sweden
Local Institution - 0184
Stockholm, , Sweden
Local Institution - 0164
Geneva, , Switzerland
Local Institution - 0189
Lausanne, , Switzerland
Local Institution - 0186
Sankt Gallen, , Switzerland
Local Institution - 0163
Zurich, , Switzerland
Local Institution - 0039
Glasgow, Dumfries & Galloway, United Kingdom
Local Institution - 0038
London, Greater London, United Kingdom
Local Institution - 0119
Manchester, Greater Manchester, United Kingdom
Local Institution - 0041
Northwood, Middlesex, United Kingdom
Local Institution - 0122
Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0037
Cambridge, , United Kingdom
Local Institution - 0040
Swansea, , United Kingdom
Countries
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References
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Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
Wolchok JD, Chiarion-Sileni V, Rutkowski P, Cowey CL, Schadendorf D, Wagstaff J, Queirolo P, Dummer R, Butler MO, Hill AG, Postow MA, Gaudy-Marqueste C, Medina T, Lao CD, Walker J, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Sandhu S, Lebbe C, Ascierto PA, Long GV, Ritchings C, Nassar A, Askelson M, Benito MP, Wang W, Hodi FS, Larkin J; CheckMate 067 Investigators. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med. 2025 Jan 2;392(1):11-22. doi: 10.1056/NEJMoa2407417. Epub 2024 Sep 15.
Mantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.
Wolchok JD, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Butler MO, Hill A, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bas T, Ritchings C, Larkin J, Hodi FS. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma. J Clin Oncol. 2022 Jan 10;40(2):127-137. doi: 10.1200/JCO.21.02229. Epub 2021 Nov 24.
Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.
Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22.
Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbe C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11.
Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Marquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.
Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.
Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2012-005371-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-067
Identifier Type: -
Identifier Source: org_study_id
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