Active, not yet recruiting
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma (CheckMate76K)
NCT No.: NCT04099251
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym: CheckMate76K
Official Title
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma (CheckMate76K)
Purpose
The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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Had a negative sentinel lymph node biopsy
Participant has not been previously treated for melanoma
ECOG 0 or 1
Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma
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Exclusion Criteria
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History of ocular or mucosal melanoma.
Pregnant or nursing women
Participants with active known or suspected autoimmune disease
Known history of allergy or hypersensitivity to study drug components
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways
Please contact the study team for additional exclusion criteria
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Keywords and/or Specific Medical Conditions
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Antineoplastic Agents, Immunological
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Immune Checkpoint Inhibitors
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Molecular Mechanisms of Pharmacological Action
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Neoplasms by Histologic Type
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Neoplasms, Germ Cell and Embryonal
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Sponsors
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