Overview

This trial is active, not recruiting.

Condition merkel cell carcinoma
Treatment gla-se
Phase phase 1
Sponsor Immune Design
Start date January 2014
End date January 2016
Trial size 10 participants
Trial identifier NCT02035657, IDC-G100-2013-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Glucopyranosyl Lipid A in Stable Emulsion
gla-se Glucopyranosyl Lipid A in Stable Emulsion
Glucopyranosyl Lipid A in Stable Emulsion

Primary Outcomes

Measure
Safety and feasibility
time frame: 1 year

Secondary Outcomes

Measure
Clinical efficacy and Immunogenicity
time frame: 1 Year
Clinical efficacy and Immunogenicity
time frame: 1 Year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease. - Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection. - ECOG performance status score 0, 1 or 2 - ≥ 18 years of age - Life expectancy of ≥ three months. - Adequate neutrophil and platelet counts - Adequate renal and hepatic function - Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy - Use of effective contraception - Signed informed consent document - Members of all genders, races and ethnic groups are eligible for this trial Exclusion Criteria: - Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment - No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents - Active, untreated brain metastases - Pregnant or nursing - Use of any systemic immunosuppressive agents - Immunosuppressed patients - Uncontrolled depression or other major psychiatric disorder

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Immune Design.