Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 8:03 PM
Study NCT ID:
NCT04675333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712178', 'term': 'ALX148'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate per RECIST 1.1', 'timeFrame': 'Last randomized patient reaching at least 24 weeks of follow-up'}], 'secondaryOutcomes': [{'measure': 'Duration of response', 'timeFrame': 'Up to 36 months'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 36 months'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 36 months'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 36 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALX148', 'CD47', 'SIRPα', 'HNSCC', 'pembrolizumab', 'evorpacept'], 'conditions': ['Head and Neck Cancer', 'Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.', 'detailedDescription': 'This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.\n* Adequate bone marrow function.\n* Adequate renal and liver function.\n* Adequate ECOG performance status.\n\nExclusion Criteria:\n\n* Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Prior treatment with any anti-CD47 or anti-SIRPα agent.\n* Prior treatment with anti-PD-1 or PD-L1.'}, 'identificationModule': {'nctId': 'NCT04675333', 'briefTitle': 'Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALX Oncology Inc.'}, 'officialTitle': 'A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)', 'orgStudyIdInfo': {'id': 'AT148004'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-B88', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': 'MK-3475-B88', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': '2020-004662-19', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-508342-17-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'evorpacept (ALX148) + pembrolizumab + Chemotherapy', 'description': 'evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.', 'interventionNames': ['Drug: evorpacept', 'Drug: pembrolizumab', 'Drug: Cisplatin/Carboplatin; 5FU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pembrolizumab + Chemotherapy', 'description': 'pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.', 'interventionNames': ['Drug: pembrolizumab', 'Drug: Cisplatin/Carboplatin; 5FU']}], 'interventions': [{'name': 'evorpacept', 'type': 'DRUG', 'otherNames': ['ALX148'], 'description': 'IV Q3W', 'armGroupLabels': ['evorpacept (ALX148) + pembrolizumab + Chemotherapy']}, {'name': 'pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA®'], 'description': 'IV Q3W', 'armGroupLabels': ['evorpacept (ALX148) + pembrolizumab + Chemotherapy', 'pembrolizumab + Chemotherapy']}, {'name': 'Cisplatin/Carboplatin; 5FU', 'type': 'DRUG', 'otherNames': ['Platinol/Paraplatin; Adrucil'], 'description': 'IV Q3W', 'armGroupLabels': ['evorpacept (ALX148) + pembrolizumab + Chemotherapy', 'pembrolizumab + Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Hospital', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedar Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University/ Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt - 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