Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-05 @ 12:25 AM
Study NCT ID:
NCT02035657
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}], 'ancestors': [{'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608161', 'term': 'glucopyranosyl lipid-A'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and feasibility', 'timeFrame': '1 year', 'description': 'The number of treatment-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Clinical efficacy and Immunogenicity', 'timeFrame': '1 Year', 'description': 'The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC'}, {'measure': 'Clinical efficacy and Immunogenicity', 'timeFrame': '1 Year', 'description': 'Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Merkel cell carcinoma', 'MCC'], 'conditions': ['Merkel Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.\n* 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.\n* ECOG performance status score 0, 1 or 2\n* ≥ 18 years of age\n* Life expectancy of ≥ three months.\n* Adequate neutrophil and platelet counts\n* Adequate renal and hepatic function\n* Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy\n* Use of effective contraception\n* Signed informed consent document\n* Members of all genders, races and ethnic groups are eligible for this trial\n\nExclusion Criteria:\n\n* Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment\n* No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents\n* Active, untreated brain metastases\n* Pregnant or nursing\n* Use of any systemic immunosuppressive agents\n* Immunosuppressed patients\n* Uncontrolled depression or other major psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT02035657', 'briefTitle': 'A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma', 'orgStudyIdInfo': {'id': 'IDC-G100-2013-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLA-SE', 'description': 'Glucopyranosyl Lipid A in Stable Emulsion', 'interventionNames': ['Biological: GLA-SE']}], 'interventions': [{'name': 'GLA-SE', 'type': 'BIOLOGICAL', 'otherNames': ['Glucopyranosyl Lipid A in Stable Emulsion'], 'description': 'Glucopyranosyl Lipid A in Stable Emulsion', 'armGroupLabels': ['GLA-SE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center, Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Frank Hsu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}