Pembrolizumab in Treating Patients With Advanced Uveal Melanoma

Stage IV Uveal Melanoma Clinical Trial

Official title: A Multicenter Phase II Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) in Patients With Advanced Uveal Melanoma

Status Terminated

Clinical Trial Summary

This phase II trial studies how well pembrolizumab works in treating patients with uveal melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate objective response rate (ORR) in patients with advanced uveal melanoma receiving pembrolizumab.

SECONDARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) in patients with advanced uveal melanoma receiving pembrolizumab.

II. To evaluate safety, tolerability and adverse experience profile of pembrolizumab in uveal melanoma.

III. To evaluate overall survival (OS) in patients with advanced uveal melanoma receiving pembrolizumab.

TERTIARY OBJECTIVES:

I. To evaluate objective response rate (ORR; complete response + partial response) in patients with advanced uveal melanoma receiving pembrolizumab as stratified by programmed cell death-ligand 1 (PD-L1) expression and guanine nucleotide-binding protein (GNA)Q/GNA11 mutation status.

II. To evaluate ORR in patients previously treated with ipilimumab or with mitogen-activated protein kinase kinase (MEK) inhibitors.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks. ;

Related Conditions & MeSH terms

• Melanoma
• Stage IIIA Uveal Melanoma
• Stage IIIB Uveal Melanoma
• Stage IIIC Uveal Melanoma
• Stage IV Uveal Melanoma
• Uveal Neoplasms

• NCT number: NCT02359851
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: May 2015
• Completion date: August 27, 2019