A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
NCT ID: NCT02905266
Last Updated: 2020-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2016-10-27
2019-10-25
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
NONE
Study Groups
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Nivolumab and Ipilimumab Concomitant Administration
Followed by Nivolumab monotherapy
Nivolumab
-Specified dose on specified days
Ipilimumab
-Specified dose on specified days
Nivolumab and Ipilimumab Sequential Administration
Followed by Nivolumab monotherapy
Nivolumab
-Specified dose on specified days
Ipilimumab
-Specified dose on specified days
Interventions
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Nivolumab
-Specified dose on specified days
Ipilimumab
-Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subjects have 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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Melanoma Institute Australia
North Sydney, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Local Institution
Lyon, , France
Hopital De La Timone
Marseille, , France
Local Institution
Nantes, , France
Hopital Saint Louis
Paris, , France
Local Institution
Paris, , France
Hopital Trousseau - Chru Tours
Tours, , France
Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med
Genova, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori
Meldola (FC), , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza
Torino, , Italy
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Seville, , Spain
Countries
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References
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Menzies AM, Salman P, Frontera OA, Pook D, Hocking CM, Zakharia Y, Gurney H, Gedye C, Goh JC, Telivala B, Grob JJ, Lebbe C, de la Cruz Merino L, Machet L, Neidhardt EM, Qureshi A, Hosein F, Hamuro L, Simsek B, Amin A. Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800). Cancer. 2025 Jul 15;131(14):e35962. doi: 10.1002/cncr.35962.
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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2016-001941-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-742
Identifier Type: -
Identifier Source: org_study_id