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

June 11, 2018 updated by: Immune Design

A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington Medical Center, Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion
Biological: GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion
Other Names:
  • Glucopyranosyl Lipid A in Stable Emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and feasibility
Time Frame: 1 year
The number of treatment-related adverse events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy and Immunogenicity
Time Frame: 1 Year
The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC
1 Year
Clinical efficacy and Immunogenicity
Time Frame: 1 Year
Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Design

Investigators

  • Study Director: Frank Hsu, MD, Immune Design

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDC-G100-2013-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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