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

NCT ID: NCT02035657

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-03-31

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.

Conditions

Merkel Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLA-SE

Glucopyranosyl Lipid A in Stable Emulsion

Group Type: EXPERIMENTAL

GLA-SE

Intervention Type: BIOLOGICAL

Glucopyranosyl Lipid A in Stable Emulsion

Interventions

GLA-SE

Glucopyranosyl Lipid A in Stable Emulsion

Intervention Type: BIOLOGICAL

Other Intervention Names

Glucopyranosyl Lipid A in Stable Emulsion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Hsu, MD

Role: STUDY_DIRECTOR

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Locations

University of Washington Medical Center, Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

Other Identifiers

IDC-G100-2013-001

Identifier Type: -

Identifier Source: org_study_id