nctId: NCT06295809 id: V940-007 id: 2023-505712-37 type: OTHER domain: EU CT id: U1111-1292-3589 type: OTHER domain: UTN id: V940 type: OTHER domain: Merck briefTitle: A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) overallStatus: RECRUITING date: 2024-05-06 date: 2029-04-30 date: 2029-04-30 date: 2024-03-06 date: 2024-04-26 name: Merck Sharp & Dohme LLC class: INDUSTRY name: Moderna TX 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. conditions: Carcinoma, Squamous Cell conditions: Skin Neoplasms studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 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 masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1012 type: ESTIMATED name: Pembrolizumab name: V940 name: Surgery measure: Event Free Survival (EFS) measure: Overall response rate (ORR) measure: Freedom from surgery (FFS) rate measure: Pathological complete response (pCR) rate measure: Major pathological response (mPR) rate measure: Disease-free survival (DFS) measure: Disease-specific survival (DSS) measure: Overall Survival (OS) measure: Percentage of participants who experience and adverse event (AE) measure: Percentage of participants who discontinue study intervention due to AEs measure: Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30) measure: Change from baseline in physical functioning score of QLQ (C30 Items 1-5) measure: Change from baseline in Role functioning score of QLQ-C30 Items 6-7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: One Clinical Research ( Site 3211) status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Study Coordinator role: CONTACT phone: +61862799466 lat: -31.98184 lon: 115.8073 facility: Hadassah Medical Center ( Site 2201) status: RECRUITING city: Jerusalem zip: 9112001 country: Israel name: Study Coordinator role: CONTACT phone: 97226777825 lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center ( Site 2202) status: RECRUITING city: Petah Tikva zip: 4941 492 country: Israel name: Study Coordinator role: CONTACT phone: 97235305201 lat: 32.08707 lon: 34.88747 hasResults: False