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