protocolSection identificationModule nctId: NCT06295809, orgStudyIdInfo id: V940-007, secondaryIdInfos id: 2023-505712-37, type: OTHER, domain: EU CT, secondaryIdInfos id: U1111-1292-3589, type: OTHER, domain: UTN, secondaryIdInfos id: V940, type: OTHER, domain: Merck, briefTitle: A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: Moderna TX, descriptionModule briefSummary: This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints., conditionsModule conditions: Carcinoma, Squamous Cell, conditions: Skin Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the Phase 2 of the study design, approximately 600 participants will be randomly assigned into 3 arms in an approximate 5:5:2 ratio (250 to V940 plus pembrolizumab with SOC, 250 participants to SOC only, and 100 participants to pembrolizumab monotherapy with SOC). If the decision is made to expand the study to Phase 3, the 600 participants enrolled in Phase 2 will keep their originally assigned study intervention arms in the Phase 3 Expansion, and 412 new participants will be enrolled and randomly assigned in a 1:1 ratio to receive treatment with either V940 plus pembrolizumab with SOC or SOC only. New participants will not be randomized into the pembrolizumab monotherapy with SOC arm during the Phase 3 Expansion., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1012, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: V940, interventions name: Surgery, outcomesModule primaryOutcomes measure: Event Free Survival (EFS), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Freedom from surgery (FFS) rate, secondaryOutcomes measure: Pathological complete response (pCR) rate, secondaryOutcomes measure: Major pathological response (mPR) rate, secondaryOutcomes measure: Disease-free survival (DFS), secondaryOutcomes measure: Disease-specific survival (DSS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Percentage of participants who experience and adverse event (AE), secondaryOutcomes measure: Percentage of participants who discontinue study intervention due to AEs, secondaryOutcomes measure: Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30), secondaryOutcomes measure: Change from baseline in physical functioning score of QLQ (C30 Items 1-5), secondaryOutcomes measure: Change from baseline in Role functioning score of QLQ-C30 Items 6-7, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: One Clinical Research ( Site 3211), status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Study Coordinator, role: CONTACT, phone: +61862799466, geoPoint lat: -31.98184, lon: 115.8073, locations facility: Hadassah Medical Center ( Site 2201), status: RECRUITING, city: Jerusalem, zip: 9112001, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: 97226777825, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center ( Site 2202), status: RECRUITING, city: Petah Tikva, zip: 4941 492, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: 97235305201, geoPoint lat: 32.08707, lon: 34.88747, hasResults: False