Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT02267603
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of MK-3475 in Patients With Advanced Merkel Cell Carcinoma (MCC)
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 Merkel cell cancer that cannot be removed by surgery or controlled with treatment, or has spread to other parts of the body. Pembrolizumab may stimulate the immune system to identify and destroy cancer cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the clinical efficacy of MK-3475 (pembrolizumab) as the first systemic intervention for patients with advanced Merkel cell carcinoma (MCC).
SECONDARY OBJECTIVES:
I. To determine the clinical activity of MK-3475 as the first systemic intervention for patients with advanced MCC.
TERTIARY OBJECTIVES:
I. To determine the immune correlates of the clinical activity of MK-3475.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity.
\* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol principal investigator (P.I.) and Cancer Immunotherapy Trials Network (CITN) P.I. approval, patients may receive treatment beyond 2 years.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 1 year, every 6 months for 2 years, annually until the patient has completed 3 years of follow up for disease assessment, and then every 12 weeks.
I. To determine the clinical efficacy of MK-3475 (pembrolizumab) as the first systemic intervention for patients with advanced Merkel cell carcinoma (MCC).
SECONDARY OBJECTIVES:
I. To determine the clinical activity of MK-3475 as the first systemic intervention for patients with advanced MCC.
TERTIARY OBJECTIVES:
I. To determine the immune correlates of the clinical activity of MK-3475.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity.
\* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol principal investigator (P.I.) and Cancer Immunotherapy Trials Network (CITN) P.I. approval, patients may receive treatment beyond 2 years.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 1 year, every 6 months for 2 years, annually until the patient has completed 3 years of follow up for disease assessment, and then every 12 weeks.
Study Oversight
Has Oversight DMC:
False
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-2014-00848 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MK-3475 | None | None | View | |
| CITN-09 | None | None | View | |
| CITN-09 | OTHER | Cancer Immunotherapy Trials Network | View | |
| CITN-09 | OTHER | CTEP | View | |
| K24CA139052 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA154967 | NIH | None | https://reporter.nih.gov/quic… | View |