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Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

Metastatic Melanoma Clinical Trial

Official title:
A Phase II Two-Arm Open-Label Study of Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

Clinical Trial Summary

This is an open-label, non-randomized two arm Phase 2 study of intravenous nivolumab plus intravenous ipilimumab or intravenous relatlimab in patients with metastatic melanoma stratified by MHC-II expression.

Clinical Trial Description

Primary Objective: • To evaluate the efficacy, measured by change in activated GZMB+ CD8+ T-cell density intratumorally, of two immunotherapy regimens in patients with advanced melanoma: - nivolumab plus relatlimab in patients with MHC-II (+) melanoma, and - nivolumab plus ipilimumab in patients with MHC-II (-) melanoma. Secondary Objectives: • To evaluate the response rate, median progression free survival, overall survival, and safety and tolerability of nivolumab plus relatlimab in patients with MHC-II (+) melanoma, and of nivolumab plus ipilimumab in patients with MHC-II (-) melanoma. Exploratory Objectives - To explore potential associations of biomarkers with clinical efficacy and/or incidence of adverse events due to study drug by analyzing biomarker measures within the peripheral blood and tumor microenvironment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03724968
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date January 17, 2019
Completion date May 28, 2020
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