Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT04675294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2025-08-01', '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 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 and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS \\> 1) and who have not received prior systemic therapy for their advanced disease.\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 has 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': 'NCT04675294', 'briefTitle': 'Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALX Oncology Inc.'}, 'officialTitle': 'A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)', 'orgStudyIdInfo': {'id': 'AT148003'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-B87', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': 'MK-3475-B87', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': '2020-004093-21', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-508340-22-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'evorpacept (ALX148) + pembrolizumab', 'description': 'evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.', 'interventionNames': ['Drug: evorpacept', 'Drug: pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pembrolizumab', 'description': 'pembrolizumab 200 mg IV given every 3 weeks.', 'interventionNames': ['Drug: pembrolizumab']}], 'interventions': [{'name': 'evorpacept', 'type': 'DRUG', 'otherNames': ['ALX148'], 'description': 'IV Q3W', 'armGroupLabels': ['evorpacept (ALX148) + pembrolizumab']}, {'name': 'pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA®'], 'description': 'IV Q3W', 'armGroupLabels': ['evorpacept (ALX148) + pembrolizumab', 'pembrolizumab']}]}, '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': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62301', 'city': 'Quincy', 'state': 'Illinois', 'country': 'United States', 'facility': 'Blessing Cancer Center', 'geoPoint': {'lat': 39.9356, 'lon': -91.40987}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11101', 'city': 'Long Island City', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '43210', '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', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt - Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2146', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane and Womens Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3051', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '5087', 'city': 'Windsor Gardens', 'country': 'Australia', 'facility': 'Ashford Cancer Centre Research', 'geoPoint': {'lat': -34.86538, 'lon': 138.64703}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': 'B - 3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'L9G2X1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences - Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LHSC - Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '1081', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VUMC Goederenontvangst', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Cancer Institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '28644', 'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '42415', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '13496', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'CHA University of Bundang', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '21565', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University - Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Medical Center (KUMC) - Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03312', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea - Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16247', 'city': 'Suwon', 'country': 'South Korea', 'facility': "Catholic University of Korea, St. Vincent's Hospital Suwon", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '26426', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Yonsei University - Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '08028', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institud Catala d´Oncologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28911', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Severo Ochoa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALX Oncology Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}