Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-14 @ 6:41 PM
Study NCT ID:
NCT03355560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2017-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-08', 'releaseDate': '2025-09-20'}, {'resetDate': '2025-10-27', 'mcpReleaseN': 10, 'releaseDate': '2025-10-14'}], 'estimatedResultsFirstSubmitDate': '2025-09-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with Grade 3 and 4 adverse events of nivolumab', 'timeFrame': '28 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients any grade adverse events of nivolumab', 'timeFrame': '28 weeks'}, {'measure': 'Disease free survival', 'timeFrame': '1 year'}, {'measure': 'Disease free survival', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '35653116', 'type': 'DERIVED', 'citation': 'Leddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options\n* Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.\n* Able to provide archived biopsy or resected tissue.\n* Adequate performance status and labs.\n\nExclusion Criteria:\n\n* Patients who did not receive at least radiotherapy as prior definitive treatment.\n* Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.\n* Has nasopharyngeal or sinonasal carcinoma.\n* Has confirmed metastatic disease.'}, 'identificationModule': {'nctId': 'NCT03355560', 'briefTitle': 'Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy', 'orgStudyIdInfo': {'id': 'UCCI-HN-17-01'}, 'secondaryIdInfos': [{'id': 'CA209-997', 'type': 'OTHER', 'domain': 'Bristol Meyers Squibb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab', 'description': 'Nivolumab starting 4-11 weeks after surgery for 6 doses.', 'interventionNames': ['Drug: Nivolumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': 'Nivolumab 480 mg IV infusion', 'armGroupLabels': ['Nivolumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'UC Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Trisha Wise-Draper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trisha Wise-Draper', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Trisha Wise-Draper', 'investigatorAffiliation': 'University of Cincinnati'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-20', 'type': 'RELEASE'}, {'date': '2025-10-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Trisha Wise-Draper, Principal Investigator, University of Cincinnati'}}}}