NCT02697630

Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

A Multicenter Phase II Open Label Study to Evaluate Efficacy of Concomitant Use of Pembrolizumab and Entinostat in Adult Patients With Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy.

Conditions

• Metastatic Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months
DRUG	Entinostat	5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months

Timeline

• Start date: 2018-02-21
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2016-03-03
• Last updated: 2023-12-08

Locations

1 site across 1 country: Sweden