Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
NCT ID: NCT02388906
Last Updated: 2025-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
906 participants
INTERVENTIONAL
2015-03-16
2024-10-16
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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Ipilimumab and Placebo matching Nivolumab
Ipilimumab
Specified dose on specified days
Placebo matching Nivolumab
Specified dose on specified days
Nivolumab and Placebo matching Ipilimumab
Nivolumab
Specified dose on specified days
Placebo matching Ipilimumab
Specified dose on specified days
Interventions
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Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Placebo matching Ipilimumab
Specified dose on specified days
Placebo matching Nivolumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Completely removed melanoma by surgery performed within 12 weeks of randomization
* Stage IIIb/C or Stage IV before complete resection
* No previous anti-cancer treatment
Exclusion Criteria
* History of carcinomatosis meningitis
* History of auto-immune disease
* Treatment directed against the resected melanoma that is administrated after the surgery
15 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 - 0036
Little Rock, Arkansas, United States
Local Institution - 0117
La Jolla, California, United States
Local Institution - 0189
Los Angeles, California, United States
Local Institution - 0021
San Francisco, California, United States
Local Institution - 0006
San Francisco, California, United States
Local Institution - 0010
Aurora, Colorado, United States
Local Institution - 0004
Washington D.C., District of Columbia, United States
Local Institution - 0012
Jacksonville, Florida, United States
Local Institution - 0019
Miami Beach, Florida, United States
Local Institution - 0030
Orlando, Florida, United States
Local Institution - 0032
Tampa, Florida, United States
Local Institution - 0016
Atlanta, Georgia, United States
Local Institution - 0106
Chicago, Illinois, United States
Local Institution - 0013
Boston, Massachusetts, United States
Local Institution - 0170
Boston, Massachusetts, United States
Local Institution - 0171
Boston, Massachusetts, United States
Local Institution - 0015
Ann Arbor, Michigan, United States
Local Institution - 0002
Robbinsdale, Minnesota, United States
Local Institution - 0017
St Louis, Missouri, United States
Local Institution - 0123
Hackensack, New Jersey, United States
Local Institution - 0095
New Brunswick, New Jersey, United States
Local Institution - 0024
New York, New York, United States
Local Institution - 0033
New York, New York, United States
Local Institution - 0003
Charlotte, North Carolina, United States
Local Institution - 0025
Durham, North Carolina, United States
Local Institution - 0157
Columbus, Ohio, United States
Local Institution - 0031
Portland, Oregon, United States
Local Institution - 0029
Portland, Oregon, United States
Local Institution - 0022
Allentown, Pennsylvania, United States
Local Institution - 0001
Bethlehem, Pennsylvania, United States
Local Institution - 0026
Charleston, South Carolina, United States
Local Institution - 0014
Nashville, Tennessee, United States
Local Institution - 0005
Dallas, Texas, United States
Local Institution - 0027
Charlottesville, Virginia, United States
Local Institution - 0126
Seattle, Washington, United States
Local Institution - 0142
Capital Federal, Buenos Aires, Argentina
Local Institution - 0140
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution
Córdoba, , Argentina
Local Institution - 0079
Gateshead, New South Wales, Australia
Local Institution - 0080
Westmead, New South Wales, Australia
Local Institution - 0078
Wollstonecraft, New South Wales, Australia
Local Institution - 0082
Greenslopes, Queensland, Australia
Local Institution - 0083
Southport, Queensland, Australia
Local Institution - 0084
Adelaide, South Australia, Australia
Local Institution - 0075
Heidelberg, Victoria, Australia
Local Institution - 0077
Prahran, Victoria, Australia
Local Institution - 0085
Nedlands, Western Australia, Australia
Local Institution - 0081
Camperdown, , Australia
Local Institution - 0169
Graz, , Austria
Local Institution - 0168
Salzburg, , Austria
Local Institution - 0038
Brussels, , Belgium
Local Institution - 0040
Brussels, , Belgium
Local Institution - 0037
Ghent, , Belgium
Local Institution - 0039
Leuven, , Belgium
Local Institution - 0051
Edmonton, Alberta, Canada
Local Institution - 0074
Vancouver, British Columbia, Canada
Local Institution - 0094
Toronto, Ontario, Canada
Local Institution - 0105
Montreal, Quebec, Canada
Local Institution - 0046
Québec, Quebec, Canada
Local Institution - 0101
Hradec Králové, , Czechia
Local Institution - 0102
Ostrava-Poruba, , Czechia
Local Institution - 0099
Prague, , Czechia
Local Institution - 0100
Prague, , Czechia
Local Institution - 0047
Helsinki, , Finland
Local Institution - 0048
Tampere, , Finland
Local Institution - 0138
Lille, , France
Local Institution - 0135
Marseille, , France
Local Institution - 0134
Nantes, , France
Local Institution - 0136
Paris, , France
Local Institution - 0133
Pierre-Bénite, , France
Local Institution - 0137
Toulouse, , France
Local Institution - 0086
Athens, , Greece
Local Institution - 0087
Neo Faliro, , Greece
Local Institution - 0163
Budapest, , Hungary
Local Institution - 0063
Dublin, , Ireland
Local Institution - 0166
Dublin, , Ireland
Local Institution - 0108
Dublin, , Ireland
Local Institution - 0064
Galway, , Ireland
Local Institution - 0112
Bergamo, , Italy
Local Institution - 0116
Genova, , Italy
Local Institution - 0115
Meldola (FC), , Italy
Local Institution - 0113
Milan, , Italy
Local Institution - 0107
Napoli, , Italy
Local Institution - 0111
Padua, , Italy
Local Institution - 0114
Roma, , Italy
Local Institution - 0110
Siena, , Italy
Local Institution - 0179
Nagoya, Aichi-ken, Japan
Local Institution - 0161
Fukuoka, Fukuoka, Japan
Local Institution - 0174
Tsukuba, Ibaraki, Japan
Local Institution - 0162
Kumamoto, Kumamoto, Japan
Local Institution - 0160
Matsumoto, Nagano, Japan
Local Institution - 0175
Niigata, Niigata, Japan
Local Institution - 0176
Osaka, Osaka, Japan
Local Institution - 0159
Sunto-gun, Shizuoka, Japan
Local Institution - 0158
Chuo-ku, Tokyo, Japan
Local Institution - 0180
Chuo-shi, Yamanashi, Japan
Local Institution - 0042
Amsterdam, , Netherlands
Local Institution - 0045
Groningen, , Netherlands
Local Institution - 0043
Nijmegen, , Netherlands
Local Institution - 0041
Veldhoven, , Netherlands
Local Institution - 0098
Bergen, , Norway
Local Institution - 0109
Oslo, , Norway
Local Institution - 0150
Gdansk, , Poland
Local Institution - 0149
Krakow, , Poland
Local Institution - 0152
Warsaw, , Poland
Local Institution - 0156
Craiova, , Romania
Local Institution - 0153
Romania, , Romania
Local Institution - 0148
Johannesburg, Gauteng, South Africa
Local Institution - 0145
Pretoria, Gauteng, South Africa
Local Institution - 0147
Saxonwold, Johannesburg, Gauteng, South Africa
Local Institution - 0181
Cape Town, Western Cape, South Africa
Local Institution - 0146
Kraaifontein, Western Cape, South Africa
Local Institution - 0144
Songpa-gu, Seoul, South Korea
Local Institution - 0129
Seoul, , South Korea
Local Institution - 0127
Seoul, , South Korea
Local Institution - 0128
Seoul, , South Korea
Local Institution - 0120
Barcelona, , Spain
Local Institution - 0119
Madrid, , Spain
Local Institution - 0121
Seville, , Spain
Local Institution - 0122
Valencia, , Spain
Local Institution - 0050
Gothenberg, , Sweden
Local Institution - 0096
Lund, , Sweden
Local Institution - 0167
Zurich, , Switzerland
Local Institution - 0131
Kaohsiung City, , Taiwan
Local Institution - 0132
Taichung, , Taiwan
Local Institution - 0130
Taoyuan District, , Taiwan
Local Institution - 0057
Bristol, Avon, United Kingdom
Local Institution - 0052
Swansea, Carmarthenshire, United Kingdom
Local Institution - 0165
London, Greater London, United Kingdom
Local Institution - 0054
Manchester, Greater Manchester, United Kingdom
Local Institution - 0056
Southampton, Hampshire, United Kingdom
Local Institution - 0177
Northwood, Middlesex, United Kingdom
Local Institution - 0055
Oxford, Oxfordshire, United Kingdom
Local Institution - 0060
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Local Institution - 0097
Leicester, , United Kingdom
Local Institution - 0053
Surrey, , United Kingdom
Countries
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References
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Ascierto PA, Del Vecchio M, Merelli B, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Gaudy-Marqueste C, Pigozzo J, Marquez-Rodas I, Butler MO, Di Giacomo AM, Gligich O, De La Cruz-Merino L, Arenberger P, Atkinson V, Nathan P, Hill A, Millward M, Fecher LA, Khushalani NI, Queirolo P, Soomro R, Rathod D, Askelson M, Pe Benito M, Joseph D, Larkin J. Nivolumab for Resected Stage III or IV Melanoma at 9 Years. N Engl J Med. 2025 Oct 18. doi: 10.1056/NEJMoa2504966. Online ahead of print.
Weber JS, Middleton MR, Yates G, Sharpe DJ, Kurt M, Lobo M, Moshyk A, Vanderpuye-Orgle J, Mohr P. Estimating Long-Term Survivorship Rates Among Patients With Resected Stage III/IV Melanoma: Analyses From CheckMate 238 and European Organization for Research and Treatment of Cancer 18071 Trials. J Clin Oncol. 2025 Mar 10;43(8):929-937. doi: 10.1200/JCO.24.00237. Epub 2024 Oct 8.
Weber J, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Larkin J. Outcomes With Postrecurrence Systemic Therapy Following Adjuvant Checkpoint Inhibitor Treatment for Resected Melanoma in CheckMate 238. J Clin Oncol. 2024 Nov;42(31):3702-3712. doi: 10.1200/JCO.23.01448. Epub 2024 Aug 5.
Larkin J, Weber J, Del Vecchio M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, De la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Mandala M. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. Eur J Cancer. 2022 Sep;173:285-296. doi: 10.1016/j.ejca.2022.06.041. Epub 2022 Aug 11.
Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.
Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8):e003188. doi: 10.1136/jitc-2021-003188.
Ascierto PA, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19.
Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2014-002351-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-238
Identifier Type: -
Identifier Source: org_study_id
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