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

NCT02697630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-12-08

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02697630 on ClinicalTrials.gov