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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 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 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.
Sponsor: Immune Design

Current Primary Outcome: Safety and feasibility [ Time Frame: 1 year ]

The number of treatment-related adverse events


Original Primary Outcome: Safety and feasibility [ Time Frame: 1 year ]

To assess the safety and tolerability of administration of GLA-SE in patients with MCC.


Current Secondary Outcome:

  • 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
  • Clinical efficacy and Immunogenicity [ Time Frame: 1 Year ]
    Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation


Original Secondary Outcome: 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


Information By: Immune Design

Dates:
Date Received: January 10, 2014
Date Started: January 2014
Date Completion: January 2017
Last Updated: July 13, 2015
Last Verified: July 2015