Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT06384820
Status:
WITHDRAWN
Last Update Posted:
2024-07-26
First Post:
2024-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-11-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2030-05-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)', 'timeFrame': 'Up to 100 days'}], 'secondaryOutcomes': [{'measure': 'pCR rate by local pathological review', 'timeFrame': 'Up to 100 days'}, {'measure': 'Major pathological response (MPR)', 'timeFrame': 'Up to 100 days'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Disease free survival (DFS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Objective response rate (ORR) prior to surgery', 'timeFrame': 'Up to 100 days'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of immune-mediated adverse events (imAEs)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of treatment-related TEAEs', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of adverse event of special interest (AESI)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of treatment-emergent serious adverse events (SAEs)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of laboratory abnormalities', 'timeFrame': 'Up to 3 years', 'description': 'Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0'}, {'measure': 'Occurrence of death due to TEAE', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of interruption of study drug(s) due to TEAEs', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of discontinuation of study drug(s) due to TEAEs', 'timeFrame': 'Up to 3 years'}, {'measure': 'Occurrence of cancellation of surgery due to TEAE', 'timeFrame': 'Up to 100 days'}, {'measure': 'Occurrence of delay to surgery due to TEAE', 'timeFrame': 'Up to 100 days'}, {'measure': 'Concentrations of cemiplimab in serum', 'timeFrame': 'Up to 3 years'}, {'measure': 'Concentrations of fianlimab in serum', 'timeFrame': 'Up to 3 years'}, {'measure': 'Concentrations of other experimental agents (as applicable) in serum', 'timeFrame': 'Up to 3 years'}, {'measure': 'Incidence of anti-drug antibodies (ADA) to cemiplimab', 'timeFrame': 'Up to 3 years'}, {'measure': 'Incidence of ADA to fianlimab', 'timeFrame': 'Up to 3 years'}, {'measure': 'Incidence of ADA to other experimental agents (as applicable)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Titer of ADA to cemiplimab', 'timeFrame': 'Up to 3 years'}, {'measure': 'Titer of ADA to fianlimab', 'timeFrame': 'Up to 3 years'}, {'measure': 'Titer of ADA to other experimental agents (as applicable)', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant', 'Adjuvant', 'Surgery'], 'conditions': ['Cutaneous Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).\n\nThe aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.\n\nThe study is looking at several other research questions, including:\n\n* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery\n* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery\n* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab\n* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice\n2. Tumor biopsy is required during screening period as described in the protocol\n3. Participant is willing to undergo delayed surgery\n4. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Stage I or II CSCC\n2. Anogenital, penile, vermilion lip CSCC\n3. CSCC bone invasion\n4. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol\n5. Prior radiation therapy for CSCC\n6. Myocardial infarction within 6 months of enrollment, or history of myocarditis.\n7. Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol\n\nNote: Other protocol-defined Inclusion/Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT06384820', 'briefTitle': 'Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)', 'orgStudyIdInfo': {'id': 'R3767-ONC-2330'}, 'secondaryIdInfos': [{'id': '2023-510514-38-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cemiplimab', 'interventionNames': ['Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'fianlimab+cemiplimab', 'interventionNames': ['Drug: cemiplimab', 'Drug: fianlimab']}], 'interventions': [{'name': 'cemiplimab', 'type': 'DRUG', 'otherNames': ['REGN2810', 'Libtayo'], 'description': 'Administered Intravenous (IV) infusion every three weeks (Q3W)', 'armGroupLabels': ['cemiplimab', 'fianlimab+cemiplimab']}, {'name': 'fianlimab', 'type': 'DRUG', 'otherNames': ['REGN3767'], 'description': 'IV infusion Q3W', 'armGroupLabels': ['fianlimab+cemiplimab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}