Clinical trial NCT02035657: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Merkel Cell Carcinoma
Keywords: Merkel cell carcinoma
MCC
Lead sponsor: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and feasibility
timeFrame: 1 year
Secondary outcomes:
measure: Clinical efficacy and Immunogenicity
timeFrame: 1 Year
measure: Clinical efficacy and Immunogenicity
timeFrame: 1 Year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center, Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Frank Hsu, MD
role: STUDY_DIRECTOR
References: