A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
NCT ID: NCT02714218
Last Updated: 2022-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
387 participants
INTERVENTIONAL
2016-04-04
2021-05-28
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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Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
Specified dose on specified days
Nivolumab 3 mg/kg IV
Followed by Nivolumab monotherapy
Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
Specified dose on specified days
Nivolumab 1 mg/kg IV
Ipilimumab 3 mg/kg IV
Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg
Specified dose on specified days
Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy
Nivolumab 6 mg/kg IV
A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.
Interventions
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Nivolumab 3 mg/kg IV
Followed by Nivolumab monotherapy
Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy
Nivolumab 1 mg/kg IV
Ipilimumab 3 mg/kg IV
Nivolumab 6 mg/kg IV
A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Exclusion Criteria
* Subjects with ocular melanoma
* Subjects with active, known or suspected 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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University Of Colorado Cancer Center
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Allina Health
Fridley, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
North Sydney, New South Wales, Australia
Local Institution - 0045
Waratah, New South Wales, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution - 0007
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Local Institution - 0063
Aarhus N, , Denmark
Local Institution - 0065
Herlev, , Denmark
Local Institution - 0064
Odense, , Denmark
Hopital Saint Andre
Bordeaux, , France
Chru De Lille
Lille, , France
Hopital De La Timone
Marseille, , France
Hopital Hotel Dieu
Nantes, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Claudius Regaud
Toulouse, , France
Local Institution - 0019
Villejuif, , France
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Ludwig-Maximilians-Universitaet
München, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Local Institution
Ramat Gan, , Israel
Local Institution - 0039
Bergamo, , Italy
Local Institution - 0042
Milan, , Italy
Local Institution - 0040
Napoli, , Italy
Istituto Oncologico Veneto IOV
Padua, , Italy
Local Institution - 0041
Siena, , Italy
Ospedale San Vincenzo
Taormina, , Italy
Local Institution - 0052
Amsterdam, , Netherlands
Local Institution
Amsterdam, , Netherlands
University Medical Center Groningen (Umcg)
Groningen, , Netherlands
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote
Gdansk, , Poland
Klinika Nowotworow Ukladowych i Uogolnionych
Krakow, , Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, , Poland
Local Institution
Moscow, , Russia
Local Institution
Badalona-barcelona, , Spain
Local Institution - 0024
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution - 0027
Madrid, , Spain
Local Institution
San Sabastian Gipuzkoa, , Spain
Local Institution
Valencia, , Spain
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Oxford, Oxfordshire, United Kingdom
Local Institution
Guildford, , United Kingdom
Local Institution
London, , 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.
Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.
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
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-511
Identifier Type: -
Identifier Source: org_study_id
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