Spots Global Cancer Trial Database for Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT03724968

Conditions

Metastatic Melanoma

Advanced Melanoma

Metastatic Melanoma Stratified by MHC-II Expression

Interventions

Nivolumab

Relatlimab

Ipilimumab

Study Description

Brief 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.

Detailed 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.