protocolSection identificationModule nctId: NCT06384820, orgStudyIdInfo id: R3767-ONC-2330, secondaryIdInfos id: 2023-510514-38-00, type: REGISTRY, domain: EU CT Number, 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), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-14, primaryCompletionDateStruct date: 2026-06-08, completionDateStruct date: 2030-05-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching an investigational drug called REGN2810, also known as cemiplimab, 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).The 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.The study is looking at several other research questions, including:* 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* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects), conditionsModule conditions: Cutaneous Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: cemiplimab, interventions name: fianlimab, outcomesModule primaryOutcomes measure: Pathological complete response (pCR) rate by blinded independent pathological review (BIPR), secondaryOutcomes measure: pCR rate by local pathological review, secondaryOutcomes measure: Major pathological response (MPR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Disease free survival (DFS), secondaryOutcomes measure: Objective response rate (ORR) prior to surgery, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Occurrence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Occurrence of immune-mediated adverse events (imAEs), secondaryOutcomes measure: Occurrence of treatment-related TEAEs, secondaryOutcomes measure: Occurrence of adverse event of special interest (AESI), secondaryOutcomes measure: Occurrence of treatment-emergent serious adverse events (SAEs), secondaryOutcomes measure: Occurrence of laboratory abnormalities, secondaryOutcomes measure: Occurrence of death due to TEAE, secondaryOutcomes measure: Occurrence of interruption of study drug(s) due to TEAEs, secondaryOutcomes measure: Occurrence of discontinuation of study drug(s) due to TEAEs, secondaryOutcomes measure: Occurrence of cancellation of surgery due to TEAE, secondaryOutcomes measure: Occurrence of delay to surgery due to TEAE, secondaryOutcomes measure: Concentrations of cemiplimab in serum, secondaryOutcomes measure: Concentrations of fianlimab in serum, secondaryOutcomes measure: Concentrations of other experimental agents (as applicable) in serum, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) to cemiplimab, secondaryOutcomes measure: Incidence of ADA to fianlimab, secondaryOutcomes measure: Incidence of ADA to other experimental agents (as applicable), secondaryOutcomes measure: Titer of ADA to cemiplimab, secondaryOutcomes measure: Titer of ADA to fianlimab, secondaryOutcomes measure: Titer of ADA to other experimental agents (as applicable), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False