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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035657 on ClinicalTrials.gov