Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 9:05 PM
Study NCT ID:
NCT07015333
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Review of Patients With Betel Nut-induced Oral Cancer Treated With Pembrolizumab and Cetuximab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-07', 'studyFirstSubmitDate': '2025-05-25', 'studyFirstSubmitQcDate': '2025-06-07', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From date first treatment received until 3 months later', 'description': 'Assessed by clinical measurement of largest tumor size'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Squamous Cell Carcinoma (OSCC)']}, 'descriptionModule': {'briefSummary': 'Chart review of records of patients treated for betel nut-induced oral cancer with pembrolizumab and cetuximab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced betel nut-induced oral cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced betel nut-induced oral cancer\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07015333', 'briefTitle': 'Case Review of Patients With Betel Nut-induced Oral Cancer Treated With Pembrolizumab and Cetuximab', 'organization': {'class': 'OTHER', 'fullName': 'Commonwealth Healthcare Corporation'}, 'officialTitle': 'Case Review of Patients With Betel Nut-induced Oral Cancer Treated With Pembrolizumab and Cetuximab', 'orgStudyIdInfo': {'id': '5-2025 Oral Cancer'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pembrolizumab and cetuximab', 'type': 'DRUG', 'description': 'Treatment of betel nut-induced oral cancer with pembrolizumab and cetuximab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '96950', 'city': 'Saipan', 'state': 'MP', 'country': 'Northern Mariana Islands', 'facility': 'CHCC', 'geoPoint': {'lat': 15.21233, 'lon': 145.7545}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Commonwealth Healthcare Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Medical Oncology', 'investigatorFullName': 'Peter Brett, MD', 'investigatorAffiliation': 'Commonwealth Healthcare Corporation'}}}}