Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT02960594
Status:
COMPLETED
Last Update Posted:
2018-11-19
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722693', 'term': 'rocakinogene sifuplasmid'}, {'id': 'D018664', 'term': 'Interleukin-12'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03', 'timeFrame': 'Up to 2 years from first study treatment'}, {'measure': 'Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site', 'timeFrame': 'Up to 14 weeks'}, {'measure': 'Changes in safety laboratory parameters', 'timeFrame': 'Up to 2 years from first study treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Human Telomerase Reverse Transcriptase (hTERT)', 'Breast Neoplasms', 'Lung Neoplasms', 'Pancreatic Neoplasms', 'High Risk of Relapse', 'Post Definitive Surgery', 'Post Adjuvant Therapy', 'No Evidence of Disease'], 'conditions': ['Breast Cancer', 'Lung Cancer', 'Pancreatic Cancer', 'Head and Neck Cancer', 'Ovarian Cancer', 'ColoRectal Cancer', 'Gastric Cancer', 'Esophageal Cancer', 'HepatoCellular Carcinoma']}, '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-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Signed and dated written IRB approved informed consent;\n* 2\\. Males or females aged ≥18 years;\n* 3\\. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:\n\n * Breast carcinoma:\n * Lung carcinoma:\n * Pancreatic carcinoma:\n * Head and neck squamous cell carcinoma:\n * Ovarian cancer:\n * Colorectal cancer\n * Gastric and esophageal cancer\n * Hepatocellular carcinoma\n\nExclusion Criteria:\n\n* 1\\. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;\n* 2\\. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;\n* 3\\. Administration of any vaccine within 4 weeks of the first study treatment'}, 'identificationModule': {'nctId': 'NCT02960594', 'acronym': 'TRT-001', 'briefTitle': 'hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse', 'nctIdAliases': ['NCT02327468'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Inovio Pharmaceuticals'}, 'officialTitle': 'A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy', 'orgStudyIdInfo': {'id': 'TRT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': '2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1400']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': '8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1400']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': '2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1400', 'Biological: INO-9012']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': '2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1400', 'Biological: INO-9012']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': '8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1400', 'Biological: INO-9012']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': '8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1400', 'Biological: INO-9012']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7', 'description': '2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1401']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8', 'description': '8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-1401']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 9', 'description': '8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-9012', 'Biological: INO-1401']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 10', 'description': '8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12', 'interventionNames': ['Biological: INO-9012', 'Biological: INO-1401']}], 'interventions': [{'name': 'INO-1400', 'type': 'BIOLOGICAL', 'otherNames': ['hTERT'], 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6']}, {'name': 'INO-9012', 'type': 'BIOLOGICAL', 'otherNames': ['IL-12'], 'armGroupLabels': ['Arm 10', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6', 'Arm 9']}, {'name': 'INO-1401', 'type': 'BIOLOGICAL', 'otherNames': ['SynCon TERT'], 'armGroupLabels': ['Arm 10', 'Arm 7', 'Arm 8', 'Arm 9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Robert Vonderheide, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Autumn McRee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Jennifer Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University Hospitial'}, {'name': 'Anthony Shields, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karmanos Cancer Center (Wayne State University)'}, {'name': 'Nathan Bahary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Ashish Chintakuntlawar, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic, Rochester, MN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inovio Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}