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

Merkel Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035657
• Other study ID #: IDC-G100-2013-001
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: March 2018

Study information

• Verified date: June 2018
• Source: Immune Design
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Merkel Cell Carcinoma

Intervention

Biological:
• GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion

Locations

Country	Name	City	State
United States	University of Washington Medical Center, Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Immune Design

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and feasibility	The number of treatment-related adverse events	1 year
Secondary	Clinical efficacy and Immunogenicity	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
Secondary	Clinical efficacy and Immunogenicity	Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation	1 Year