protocolSection identificationModule nctId: NCT06307431, orgStudyIdInfo id: V940-004, secondaryIdInfos id: 2023-505177-32, type: OTHER, domain: EU CT, briefTitle: A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2028-01-08, completionDateStruct date: 2032-06-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: ModernaTX, Inc., descriptionModule briefSummary: The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS., conditionsModule conditions: Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 272, type: ESTIMATED, armsInterventionsModule interventions name: V940, interventions name: Pembrolizumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease-Free Survival (DFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Distant Metastasis-free survival (DMFS), secondaryOutcomes measure: Percentage of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Percentage of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0102), status: RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 203-785-5720, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 1502), status: RECRUITING, city: Macquarie University, state: New South Wales, zip: 2109, country: Australia, contacts name: Study Coordinator, role: CONTACT, phone: +61 2 9812 3526, locations facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008), status: RECRUITING, city: Québec, state: Quebec, zip: G1R 2J6, country: Canada, contacts name: Study Coordinator, role: CONTACT, phone: 4185254444, geoPoint lat: 46.81228, lon: -71.21454, locations facility: FALP-UIDO ( Site 1202), status: RECRUITING, city: Santiago, state: Region M. De Santiago, zip: 7500921, country: Chile, contacts name: Study Coordinator, role: CONTACT, phone: 56224457254, geoPoint lat: -33.45694, lon: -70.64827, locations facility: ONCOCENTRO APYS-ACEREY ( Site 1200), status: RECRUITING, city: Viña del Mar, state: Valparaiso, zip: 2520598, country: Chile, contacts name: Study Coordinator, role: CONTACT, phone: +56992369820, geoPoint lat: -33.02457, lon: -71.55183, hasResults: False