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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Melanoma MedlinePlus related topics: Melanoma Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma Drug Information available for: Ipilimumab Nivolumab Relatlimab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Parallel Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Arm A Nivolumab and Relatlimab Drug : Nivolumab Nivolumab will be given by vein on day 1 of each cycle. Drug : Relatlimab Relatlimab will be given by vein on day 1 of each 28-day cycle Experimental : Arm B Nivolumab and Ipilimumab Drug : Nivolumab Nivolumab will be given by vein on day 1 of each cycle. Drug : Ipilimumab Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days). Primary Outcome Measures Outcome Measure Measure Description Time Frame Change in Activated GZMB+ CD8+T-cell Density Intratumorally, of Two Immunotherapy Regimens Approximately 16 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Response Rate Approximately 16 months Median Progression Free Survival Approximately 16 months Median Overall Survival Approximately 16 months Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE Version 5.0 Up to 30 days from last dose of drugs (average of 13 cycles) Additional Relevant MeSH Terms 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 Ipilimumab Relatlimab Plan to Share Individual Participant Data (IPD)? Undecided Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by Elizabeth Davis, Vanderbilt-Ingram Cancer Center Study Protocol and Statistical Analysis Plan [ PDF , 4.72MB, 2020-03-30 ] Revision: v2.9.1'
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