Clinical Trials Directory

Trials / Terminated

TerminatedNCT02359851

Pembrolizumab in Treating Patients With Advanced Uveal Melanoma

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Vanderbilt-Ingram Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPembrolizumabGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2015-05-01
Primary completion
2017-05-01
Completion
2019-08-27
First posted
2015-02-10
Last updated
2019-09-18
Results posted
2018-04-24

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02359851. Inclusion in this directory is not an endorsement.