A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
NCT02035657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2018-06-13
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.
Conditions
Interventions
- BIOLOGICAL
-
GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion
Sponsors & Collaborators
-
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
lead INDUSTRY
Principal Investigators
-
Frank Hsu, MD · Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2018-03-31
- Completion
- 2018-03-31
Countries
- United States
Study Locations
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