The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Pembrolizumab in Treating Patients With Advanced Uveal Melanoma
Official Title: A Multicenter Phase II Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) in Patients With Advanced Uveal Melanoma
Study 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago, Chicago, Illinois, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Name: Douglas Johnson
Affiliation: Vanderbilt-Ingram Cancer Center
Role: PRINCIPAL_INVESTIGATOR