NCT02035657

A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 patient's 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 patient's own immune system in attacking the cancer cells.

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	GLA-SE	Glucopyranosyl Lipid A in Stable Emulsion

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2014-01-14
• Last updated: 2018-06-13

Locations

1 site across 1 country: United States