NCT03724968

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Elizabeth Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Melanoma
• Advanced Melanoma
• Metastatic Melanoma Stratified by MHC-II Expression

Interventions

Type	Name	Description
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
DRUG	Ipilimumab	Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).

Timeline

• Start date: 2019-01-17
• Primary completion: 2020-05-28
• Completion: 2020-05-28
• First posted: 2018-10-30
• Last updated: 2021-04-20
• Results posted: 2021-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study