Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT02359851
Status:
TERMINATED
Last Update Posted:
2019-09-18
First Post:
2015-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pembrolizumab in Treating Patients With Advanced Uveal Melanoma
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00020 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |