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

Primary Purpose

Merkel Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GLA-SE

About this trial

This is an interventional treatment trial for Merkel Cell Carcinoma focused on measuring Merkel cell carcinoma, MCC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Washington Medical Center, Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GLA-SE

Arm Description

Glucopyranosyl Lipid A in Stable Emulsion

Outcomes

Primary Outcome Measures

Safety and feasibility

The number of treatment-related adverse events

Secondary Outcome Measures

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

Clinical efficacy and Immunogenicity

Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation

Full Information

NCT ID

NCT02035657

First Posted

January 10, 2014

Last Updated

June 11, 2018

Sponsor

Immune Design

1. Study Identification

Unique Protocol Identification Number

NCT02035657

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immune Design

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Merkel Cell Carcinoma

Keywords

Merkel cell carcinoma, MCC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLA-SE

Arm Type

Experimental

Arm Description

Glucopyranosyl Lipid A in Stable Emulsion

Intervention Type

Biological

Intervention Name(s)

GLA-SE

Other Intervention Name(s)

Glucopyranosyl Lipid A in Stable Emulsion

Intervention Description

Glucopyranosyl Lipid A in Stable Emulsion

Primary Outcome Measure Information:

Title

Safety and feasibility

Description

The number of treatment-related adverse events

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Clinical efficacy and Immunogenicity

Description

The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC

Time Frame

1 Year

Title

Clinical efficacy and Immunogenicity

Description

Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Hsu, MD

Organizational Affiliation

Immune Design

Official's Role

Study Director

Facility Information:

Facility Name

University of Washington Medical Center, Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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