Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
NCT ID: NCT00636168
Last Updated: 2019-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1211 participants
INTERVENTIONAL
2008-06-30
2018-11-26
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
DOUBLE
Study Groups
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A
ipilimumab
IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
B
Placebo
IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
Interventions
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ipilimumab
IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
Placebo
IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
* Disease-free
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Randomization within 12 weeks of surgery
Exclusion Criteria
* Auto-immune disease
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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The Angeles Clinic & Research Institute
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
North. Cal. Melanoma Center-St. Mary's Medical Center
San Francisco, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, United States
H Lee Moffitt Cancer Cnt And Res Inst
Tampa, Florida, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
Atlantic Melanoma Center
Morristown, New Jersey, United States
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
St Lukes Hospital And Health Network
Bethlehem, Pennsylvania, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, United States
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
Waratah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Greenslopes, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Box Hill, Victoria, Australia
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Malvern, Victoria, Australia
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Nedlands, Western Australia, Australia
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Graz, , Austria
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Vienna, , Austria
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Ghent, , Belgium
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Leuven, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Montreal, Quebec, Canada
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Prague, , Czechia
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Prague, , Czechia
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Aarhus C, , Denmark
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Herlev, , Denmark
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Odense C, , Denmark
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Helsinki, , Finland
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Turku, , Finland
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Lillie, Cedex, France
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Boulogne-Billancourt, , France
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Marseille, , France
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Paris, , France
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Paris, , France
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Pierre-Bénite, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Berlin, , Germany
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Cologne, , Germany
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Essen, , Germany
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Göttingen, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Mannheim, , Germany
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Tübingen, , Germany
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Würzburg, , Germany
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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Siena, , Italy
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Oslo, , Norway
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Poznan, , Poland
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Warsaw, , Poland
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Pyatigorsk, Stavropol Kray, Russia
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Ivanovo, , Russia
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Izhevsk, , Russia
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Krasnodar, , Russia
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Krasnoyarsk, , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Tomsk, , Russia
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Ufa, , Russia
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Barcelona, , Spain
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Madrid, , Spain
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Zaragoza, , Spain
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Stockholm, , Sweden
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Zurich, , Switzerland
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Chelmsford, Essex, United Kingdom
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London, Greater London, United Kingdom
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Southampton, Hampshire, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Leeds, Yorkshire, United Kingdom
Countries
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References
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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 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.
Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Bottomley A, Kotapati S, de Pril V, Testori A, Eggermont AMM. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017 Mar;18(3):393-403. doi: 10.1016/S1470-2045(17)30015-3. Epub 2017 Feb 3.
Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Bastholt L, Mortier L, Thomas L, Tahir S, Hauschild A, Hassel JC, Hodi FS, Taitt C, de Pril V, de Schaetzen G, Suciu S, Testori A. Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy. N Engl J Med. 2016 Nov 10;375(19):1845-1855. doi: 10.1056/NEJMoa1611299. Epub 2016 Oct 7.
Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Konto C, Hoos A, de Pril V, Gurunath RK, de Schaetzen G, Suciu S, Testori A. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 May;16(5):522-30. doi: 10.1016/S1470-2045(15)70122-1. Epub 2015 Mar 31.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry form
BMS clinical trial educational resource
Other Identifiers
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EORTC 18071
Identifier Type: -
Identifier Source: secondary_id
CA184-029
Identifier Type: -
Identifier Source: org_study_id