Ignite Creation Date:
2024-05-06 @ 2:23 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02035657
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2014-01-10
Brief Title:
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
Sponsor:
Immune Design a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Immune Design a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE a Toll-like Receptor-4 Agonist in Patients With Merkel Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-06
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 is a single arm open-label single center study evaluating the safety feasibility clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma Ten patients will be treated The goal is for GLA-SE to assist the patients own immune system in attacking the cancer cells
Detailed Description:
This is a single arm open-label single center study evaluating the safety feasibility clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma Ten patients with metastatic or locoregional disease will be treated The goal is for GLA-SE to assist the patients own immune system in attacking the cancer cells
Study Oversight
Has Oversight DMC:
None
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?:
None