Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06041802
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 40 months', 'description': 'ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 40 months', 'description': 'For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 40 months', 'description': 'DCR is defined, per RECIST 1.1, as the percentage of participants who demonstrate a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD \\[at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.\\]).The DCR as assessed by BICR will be presented.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 40 months', 'description': 'OS is defined as the time from first dose of study treatment to death due to any cause.'}, {'measure': 'Number of Participants who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be reported.'}, {'measure': 'Number of Participants who Discontinue Due to an AE', 'timeFrame': 'Up to approximately 25 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Squamous Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) pembrolizumab (+) berahyaluronidase alfa in Japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that pembrolizumab (+) berahyaluronidase alfa will result in greater than 10% objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histologically confirmed cSCC by the investigator as the primary site of malignancy\n* R/M cSCC cohort only: Has metastatic disease, defined as disseminated disease distant to the initial/primary site of diagnosis, and/or has locally recurrent disease that has been previously treated (with either surgery or radiotherapy) and is not curable by either surgery or radiotherapy\n* LA unresectable cSCC cohort only: Is ineligible for surgical resection\n* LA unresectable cSCC cohort only: Has received prior radiation therapy (RT) to index site or has been deemed to be not eligible for RT\n* LA unresectable cSCC cohort only: Has received prior systemic therapy for curative intent are eligible regardless of regimen\n* Has a life expectancy of greater than 3 months\n* Must provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\n\nExclusion Criteria:\n\n* Has cSCC that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.\n* Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study\n* Has received prior systemic anticancer therapy including investigation agents within 4 weeks before allocation\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* Received prior radiotherapy within 2 weeks of study intervention, or had radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has an ongoing active infection requiring systemic therapy\n* Has a history of human immunodeficiency virus (HIV) infection\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n* Has history of allogenic tissue/organ transplant'}, 'identificationModule': {'nctId': 'NCT06041802', 'briefTitle': 'A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MK-3475A in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC.', 'orgStudyIdInfo': {'id': '3475A-E39'}, 'secondaryIdInfos': [{'id': 'MK-3475A-E39', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2041230074', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials (jRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab (+) Berahyaluronidase alfa', 'description': 'Participants will receive pembrolizumab (+) berahyaluronidase alfa subcutaneously for up to 18 administrations.', 'interventionNames': ['Biological: Pembrolizumab (+) Berahyaluronidase alfa']}], 'interventions': [{'name': 'Pembrolizumab (+) Berahyaluronidase alfa', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475A'], 'description': 'Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab and berahyaluronidase alfa for SC administration.', 'armGroupLabels': ['Pembrolizumab (+) Berahyaluronidase alfa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-52-741-2111'}], 'facility': 'Nagoya University Hospital ( Site 0003)', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '060-8543', 'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+081 11-611-2111'}], 'facility': 'Sapporo Medical University Hospital ( Site 0002)', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '236-0004', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-45-787-2800'}], 'facility': 'Yokohama City University Hospital ( Site 0016)', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '980-8574', 'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-22-717-7000'}], 'facility': 'Tohoku University Hospital ( Site 0019)', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '390-8621', 'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-263-35-4600'}], 'facility': 'Shinshu University Hospital ( Site 0011)', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '951-8566', 'city': 'Niigata', 'state': 'Niigata', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-25-266-5111'}], 'facility': 'Niigata Cancer Center Hospital ( Site 0005)', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '350-1298', 'city': 'Hidaka', 'state': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-42-984-4111'}], 'facility': 'Saitama Medical University International Medical Center ( Site 0008)', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'zip': '693-8501', 'city': 'Izumo', 'state': 'Shimane', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-853-23-2111'}], 'facility': 'Shimane University Hospital ( Site 0014)', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'zip': '411-8777', 'city': 'Nagaizumi-cho,Sunto-gun', 'state': 'Shizuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-55-989-5222'}], 'facility': 'Shizuoka Cancer Center ( Site 0004)'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81335422511'}], 'facility': 'National Cancer Center Hospital ( Site 0007)'}, {'zip': '135-8550', 'city': 'Koto', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-3-3520-0111'}], 'facility': 'Cancer Institute Hospital of JFCR ( Site 0018)'}, {'zip': '260-8677', 'city': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-43-222-7171'}], 'facility': 'Chiba University Hospital ( Site 0001)', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '811-1395', 'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '81-92-541-3231'}], 'facility': 'National Hospital Organization Kyushu Cancer Center ( Site 0017)', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '892-0853', 'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-99-223-1151'}], 'facility': 'National Hospital Organization Kagoshima Medical Center ( Site 0013)', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '602-8566', 'city': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-75-251-5111'}], 'facility': 'University Hospital,Kyoto Prefectural University of Medicine ( Site 0012)', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '541-8567', 'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81669451181'}], 'facility': 'Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0009)', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '1608582', 'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-3-3353-1211'}], 'facility': 'Keio University Hospital ( Site 0010)', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '641-8510', 'city': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-73-447-2300'}], 'facility': 'Wakayama Medical University Hospital ( Site 0015)', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}