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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma

Conditions
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Merkel Cell Carcinoma

Intervention / Treatment
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* Biological: GLA-SE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLA-SE<br>Glucopyranosyl Lipid A in Stable Emulsion | Biological: GLA-SE<br>* Glucopyranosyl Lipid A in Stable Emulsion<br>* Other names: Glucopyranosyl Lipid A in Stable Emulsion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and feasibility | The number of treatment-related adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Clinical efficacy and Immunogenicity | Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Merkel cell carcinoma, MCC