protocolSection identificationModule nctId: NCT06305767, orgStudyIdInfo id: V940-005, secondaryIdInfos id: V940-005, type: OTHER, domain: Merck, secondaryIdInfos id: U1111-1292-1952, type: OTHER, domain: WHO, secondaryIdInfos id: 2023-505658-17, type: OTHER, domain: EU CT, briefTitle: A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-10-08, completionDateStruct date: 2031-04-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: ModernaTX, Inc., descriptionModule briefSummary: The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: V940, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease Free Survival (DFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Distant Metastasis-Free Survival (DMFS), secondaryOutcomes measure: Number of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102), status: RECRUITING, city: Orlando, state: Florida, zip: 32804, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 205-520-6512, geoPoint lat: 28.53834, lon: -81.37924, locations facility: One Clinical Research ( Site 1807), 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: Centre Hospitalier de l'Université de Montréal ( Site 0005), status: RECRUITING, city: Montréal, state: Quebec, zip: H2X 3E4, country: Canada, contacts name: Study Coordinator, role: CONTACT, phone: 5148908000, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, status: RECRUITING, city: Quebec City, state: Quebec, zip: G1J 1Z4, country: Canada, contacts name: Study Coordinator, role: CONTACT, phone: 4185254444, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801), status: RECRUITING, city: Bydgoszcz, state: Kujawsko-pomorskie, zip: 85-796, country: Poland, contacts name: Study Coordinator, role: CONTACT, phone: 48501446778, geoPoint lat: 53.1235, lon: 18.00762, locations facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003), status: RECRUITING, city: Pozuelo de Alarcon, state: Madrid, zip: 28223, country: Spain, contacts name: Study Coordinator, role: CONTACT, phone: +34914521987, geoPoint lat: 40.43293, lon: -3.81338, hasResults: False