Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02359851
Brief 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.
Study:
NCT02359851
Study Brief:
Protocol Section:
NCT02359851