Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04129320
Status:
WITHDRAWN
Last Update Posted:
2022-02-08
First Post:
2019-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in study design', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (Modules X and Y)', 'timeFrame': '2 years', 'description': 'Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1'}, {'measure': 'Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)', 'timeFrame': 'Up to 30 days after last dose of study drug', 'description': 'Evaluation of adverse events and serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival - (Modules X and Y)', 'timeFrame': '2 years', 'description': 'Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.'}, {'measure': 'Disease Control Rate - (Modules X and Y)', 'timeFrame': '2 years', 'description': 'Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment'}, {'measure': 'Duration of Response - (Modules X and Y)', 'timeFrame': '2 years', 'description': 'Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first'}, {'measure': 'Immunogenicity (Module X)', 'timeFrame': '2 years', 'description': 'Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012'}, {'measure': 'Immunogenicity (Module Y)', 'timeFrame': '2 years', 'description': 'Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013'}, {'measure': 'Cmax (Module X)', 'timeFrame': '2 years', 'description': 'Maximum serum concentration of enoblituzumab and MGA012'}, {'measure': 'Ctrough (Module X)', 'timeFrame': '2 years', 'description': 'Trough serum concentration of enoblituzumab and MGA012'}, {'measure': 'Cmax (Module Y)', 'timeFrame': '2 years', 'description': 'Maximum serum concentration of enoblituzumab and MGD013'}, {'measure': 'Ctrough (Module Y)', 'timeFrame': '2 years', 'description': 'Trough serum concentration of enoblituzumab and MGD013'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SCCHN', 'head and neck', 'oropharyngeal', 'oral cavity', 'hypopharyngeal', 'laryngeal cancer', 'immunotherapy', 'PD-1', 'B7-H3', 'LAG-3'], 'conditions': ['Head and Neck Cancer', 'Squamous Cell Carcinoma of Head and Neck']}, 'descriptionModule': {'briefSummary': 'This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).', 'detailedDescription': 'The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30 patients each, will occur independently in a non-randomized fashion. Data from these modules will determine if further evaluation will occur in randomized Module A (Phase 2) and randomized Module B (Phase 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven, recurrent or metastatic SCCHN not curable by local therapy\n* No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \\> 6 months prior of given as part of multimodal treatment for locally advanced disease)\n* Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx\n* At least one radiographically measurable lesion\n* HPV test results available (positive and negative eligible)\n* ECOG Performance status of 0 or 1\n* Adequate end organ function\n* Positive PD-L1 expression level (CPS ≥ 1%)\n\nExclusion Criteria:\n\n* Disease suitable for local therapy administered with curative intent\n* Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN\n* Radiation or other non-systemic therapy within 2 weeks of first dose of study drug\n* Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug'}, 'identificationModule': {'nctId': 'NCT04129320', 'briefTitle': 'Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck', 'organization': {'class': 'INDUSTRY', 'fullName': 'MacroGenics'}, 'officialTitle': 'A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'CP-MGA271-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 1', 'description': 'Enoblituzumab plus MGA012', 'interventionNames': ['Biological: enoblituzumab', 'Biological: MGA012']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 2', 'description': 'Enoblituzumab plus MGD013', 'interventionNames': ['Biological: enoblituzumab', 'Biological: MGD013']}], 'interventions': [{'name': 'enoblituzumab', 'type': 'BIOLOGICAL', 'otherNames': ['MGA271'], 'description': 'anti-B7-H3 antibody', 'armGroupLabels': ['Experimental Arm 1', 'Experimental Arm 2']}, {'name': 'MGA012', 'type': 'BIOLOGICAL', 'otherNames': ['INCMGA00012'], 'description': 'anti-PD-1 antibody', 'armGroupLabels': ['Experimental Arm 1']}, {'name': 'MGD013', 'type': 'BIOLOGICAL', 'description': 'PD-1 X LAG-3 bispecific DART protein', 'armGroupLabels': ['Experimental Arm 2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MacroGenics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}