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Brief Title: A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
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
Study ID: NCT02035657
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Washington Medical Center, Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Frank Hsu, MD
Affiliation: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Role: STUDY_DIRECTOR