Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
NCT ID: NCT01515189
Last Updated: 2019-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
831 participants
INTERVENTIONAL
2012-02-17
2017-08-17
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 1: Ipilimumab (3 mg/kg)
Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Ipilimumab
Arm 2: Ipilimumab (10 mg/kg)
Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Ipilimumab
Interventions
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Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* History of autoimmune 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 And Research Institute
Los Angeles, California, United States
University Of California Los Angeles
Los Angeles, California, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
St. Luke's Cancer Center - Anderson Campus
Easton, Pennsylvania, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
San Miguel de Tucumán, Tucumán Province, Argentina
Fundacion Cidea
Buenos Aires, , Argentina
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Camperdown, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Brisbane, Queensland, Australia
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Southport, Queensland, Australia
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Adelaide, South Australia, Australia
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Heidelberg, Victoria, Australia
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Linz, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Edmonton, Alberta, Canada
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Halfax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Aarhus, , Denmark
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Herlev, , Denmark
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Odense, , Denmark
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Bordeaux, , France
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Dijon, , France
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Grenoble, , France
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Lille, , France
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Marseille, , France
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Nantes, , France
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Paris, , France
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Pierre-Bénite, , France
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Reims, , France
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Toulouse, , France
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Villejuif, , France
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Buxtehude, , Germany
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Essen, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Mainz, , Germany
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Munich, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Kaposvár, , Hungary
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Szeged, , Hungary
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Jerusalem, , Israel
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Meldola (fc), , 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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Leon, Guanajato, Guanajuato, Mexico
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Leiden, , Netherlands
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Bergen, , Norway
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Oslo, , Norway
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Gdansk, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Cape Town, Western Cape, South Africa
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George, Western Cape, South Africa
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Rondebosch, Western Cape, South Africa
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Navarra, , Spain
Instituto Valenciano De Oncologia
Valencia, , Spain
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Valencia, , Spain
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Gothenberg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Lausanne, , Switzerland
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Manchester, Greater Manchester, United Kingdom
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Glasgow, Scotland, Strathclyde, United Kingdom
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London, , United Kingdom
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Swansea, , United Kingdom
Countries
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References
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Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbe C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1):e000391. doi: 10.1136/jitc-2019-000391.
Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.
Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbe C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2011-004029-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-169
Identifier Type: -
Identifier Source: org_study_id
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