Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
NCT ID: NCT02599402
Last Updated: 2021-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
533 participants
INTERVENTIONAL
2015-12-20
2020-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination therapy: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab specified dose on specified days
Nivolumab
Ipilimumab
Monotherapy: Nivolumab
Nivolumab specified dose on specified days
Nivolumab
Interventions
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Nivolumab
Ipilimumab
Eligibility Criteria
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Inclusion Criteria
* Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.
NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.
* Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (\>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.
Exclusion Criteria
* Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.
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
Garran, Australian Capital Territory, Australia
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Camperdown, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Gateshead, New South Wales, Australia
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North Sydney, New South Wales, Australia
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Tiwi, Northern Territory, Australia
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Brisbane, Queensland, Australia
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Cairns, Queensland, Australia
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Greenslopes, Queensland, Australia
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Southport, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Hobart, Tasmania, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Graz, , Austria
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Innsbruck, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Helsinki, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Turku, , Finland
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Angers, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Grenoble, , France
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Le Mans, , France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Pierre Benite Cedax, , France
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Rennes, , France
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Rouen, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Mainz, Rhineland-palladium, Germany
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Berlin, , Germany
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Dresden, , Germany
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Erfurt, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Göttingen, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Ludwigshafen, , Germany
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Lübeck, , Germany
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Mannheim, , Germany
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Regensburg, , Germany
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Schwerin, , Germany
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Stade, , Germany
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Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Bari, , Italy
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Bergamo, , Italy
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Genova, , Italy
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Meldola, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Siena, , Italy
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Terni, , Italy
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Torino, , Italy
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Oslo, , Norway
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Stavanger, , Norway
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Eskilstuna, , Sweden
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Gävle, , Sweden
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Karlskrona, , Sweden
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Linköping, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Vaxjo, , Sweden
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Västerås, , Sweden
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Basel, , Switzerland
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Lausanne, , Switzerland
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London, Greater London, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, United Kingdom
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Cambridge, , United Kingdom
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Cottingham, , United Kingdom
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Glasgow, , United Kingdom
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Headington, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Mount Vernon Hospital
Northwood, , United Kingdom
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Nottingham, , United Kingdom
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Preston, , United Kingdom
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Sheffield, , United Kingdom
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Southampton, , United Kingdom
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Swansea, , United Kingdom
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Truro, , United Kingdom
Countries
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References
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Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbe C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M. First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401. J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.
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
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2015-001274-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-401
Identifier Type: -
Identifier Source: org_study_id
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