Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-06 @ 2:37 AM
Study NCT ID:
NCT02241369
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2014-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722693', 'term': 'rocakinogene sifuplasmid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-12', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to new anti-cancer therapy', 'timeFrame': 'First dose to Week 26'}], 'primaryOutcomes': [{'measure': 'Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03', 'timeFrame': 'Up to 6 months'}, {'measure': 'Injection site reactions including skin erythema, induration pain and tenderness at administration site', 'timeFrame': 'Up to 15 weeks'}], 'secondaryOutcomes': [{'measure': 'HPV6 specific Ig levels', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of antigen-specific IFN-γ-secreting cells in response to stimulation with HPV6 by antigen-specific IFN-γ ELISpot assays', 'timeFrame': 'Up to 6 months'}, {'measure': 'Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry', 'timeFrame': 'Up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aerodigestive Lesions and Malignancies', 'Human Papillomavirus', 'Squamous Cell Carcinoma'], 'conditions': ['Aerodigestive Precancerous Lesions and Malignancies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.inovio.com', 'label': "Sponsor's Website"}]}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.', 'detailedDescription': 'This is a Phase I, open-label, study to evaluate the safety, tolerability, and immunogenicity of 3 mg or 6 mg INO-3106 alone or in combination with 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in subjects with HPV6 associated aerodigestive precancerous lesions and malignancies. Subjects will be enrolled in 2 cohorts (3 subjects in each cohort):\n\nCohort I: First 3 subjects will be enrolled sequentially and will receive INO-3106 alone or in combination with INO-9012.\n\nCohort II: The next 3 subjects will be treated with 6 mg of INO-3106 and 1 mg of INO-9012, or at the MTD (Maximum Tolerated Dose) determined in Cohort I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated written Ethics Committee approved informed consent\n* Age ≥18 years\n* Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradiation/chemotherapy; or\n* Histologically documented HPV-6 positive papilloma or HPV-6 related premalignant lesion (i.e., carcinoma in situ) in aerodigestive or head and neck regions.\n* Prior to study entry, subjects will have exhausted all treatments that are/have been used in these indications which may include any combination of surgery, anti-viral therapy, chemotherapy and/or radiation therapy.\n* Core biopsy must be obtained prior to enrollment to confirm invasive cancer. Archival material is allowed.\n* Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥ 9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN), AST, ALT within 2.5x ULN, CPK within 2.5 x ULN, serum creatinine ≤ 1.5x ULN\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0-2\n\nExclusion Criteria:\n\n* Participation in a clinical trial within 30 days before entry\n* Any cardiac pre-excitation syndromes, e.g. Wolff-Parkinson-White syndrome\n* Presence of metal implants within 5 cm of the planned site(s) of injection\n* Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids)\n* Administration of any vaccine within 6 weeks of enrollment'}, 'identificationModule': {'nctId': 'NCT02241369', 'briefTitle': 'Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inovio Pharmaceuticals'}, 'officialTitle': 'A Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Precancerous Lesions and Malignancies', 'orgStudyIdInfo': {'id': 'HPV-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort I', 'description': '3 mg of INO-3106 (D0); 6 mg of INO-3106 (Wk3); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk6); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk9);', 'interventionNames': ['Biological: INO-3106, INO-9012']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort II', 'description': '6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9', 'interventionNames': ['Biological: INO-3106, INO-9012']}], 'interventions': [{'name': 'INO-3106, INO-9012', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Cohort I', 'Cohort II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jeffrey Skolnik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inovio Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inovio Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}