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

Phase 1

Completed

• Conditions: Merkel Cell Carcinoma
• Interventions: Biological: GLA-SE

• Registration Number: NCT02035657
• Lead Sponsor: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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 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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLA-SE	GLA-SE	Glucopyranosyl Lipid A in Stable Emulsion

Primary Outcome Measures

Name	Time	Method
Safety and feasibility	1 year	The number of treatment-related adverse events

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy and Immunogenicity	1 Year	Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation

Trial Locations

Locations (1)

University of Washington Medical Center, Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States