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| Overall Recruitment Status: Active, not yet recruiting |
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| 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) |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
| CheckMate76K |
NCT04099251 |
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| Study Type |
Phase |
| INTERVENTIONAL |
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| 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. |
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| Detailed Description |
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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
Please contact the study team for additional inclusion 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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- Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Melanoma
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Nivolumab
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