Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT00651703
Status:
COMPLETED
Last Update Posted:
2010-11-15
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712049', 'term': 'Monatide (IMS 3015)'}, {'id': 'D000077271', 'term': 'Imiquimod'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-11', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-01', 'lastUpdatePostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmed Stage III or IV malignant melanoma\n* HLA-A\\*0201 haplotype\n* Expected survival of at least 9 months\n* Willing and able to comply with all trial requirements (e.g. diaries, CTs)\n* Given written informed consent\n* Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception\n\nExclusion Criteria:\n\n* Any contraindication to any study related test or assessment\n* Current or planned use of contraindicated concomitant medication\n* Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease\n* Infection with HIV, HBV or HCV\n* Pregnancy or lactation or females planning to become pregnant during the study\n* Abuse of alcohol or other drugs\n* Use of investigational drug within 30 days before enrolment\n* Previous participation in a clinical trial with a Qb-based Cytos vaccine.'}, 'identificationModule': {'nctId': 'NCT00651703', 'briefTitle': 'Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytos Biotechnology AG'}, 'officialTitle': 'Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma', 'orgStudyIdInfo': {'id': 'CYT004-MelQbG10 04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: CYT004-MelQbG10 + Montanide']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Biological: CYT004-MelQbG10 + Montanide + Imiquimod']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Biological: CYT004-MelQbG10 + Imiquimod']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Biological: CYT004-MelQbG10 intra nodal injection']}], 'interventions': [{'name': 'CYT004-MelQbG10 + Montanide', 'type': 'BIOLOGICAL', 'armGroupLabels': ['1']}, {'name': 'CYT004-MelQbG10 + Montanide + Imiquimod', 'type': 'BIOLOGICAL', 'armGroupLabels': ['2']}, {'name': 'CYT004-MelQbG10 + Imiquimod', 'type': 'BIOLOGICAL', 'armGroupLabels': ['3']}, {'name': 'CYT004-MelQbG10 intra nodal injection', 'type': 'BIOLOGICAL', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-1005', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Ludwig Institute for Cancer Research; CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'CH-8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Dermatologische Klinik, UniversitätsSpital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytos Biotechnology AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Head Clinical Development', 'oldOrganization': 'Cytos Biotechnology AG'}}}}