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

NCT02035657 | Completed Phase 1 DMC

• 1 other identifier: IDC-G100-2013-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Merkel Cell Carcinoma

Keywords

Merkel cell carcinoma; MCC

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility

  The number of treatment-related adverse events

  1 year

Secondary Outcomes (2)

• Clinical efficacy and Immunogenicity

  1 Year

• Clinical efficacy and Immunogenicity

  1 Year

Study Arms (1)

GLA-SE

EXPERIMENTAL

Glucopyranosyl Lipid A in Stable Emulsion

Biological: GLA-SE

Interventions

GLA-SE BIOLOGICAL

Glucopyranosyl Lipid A in Stable Emulsion

Also known as: Glucopyranosyl Lipid A in Stable Emulsion

GLA-SE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Washington Medical Center, Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

glucopyranosyl lipid-A

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Frank Hsu, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

US (1)