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klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit 81675 Munich (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 498941402522» Ansprechpartner anzeigenCaritas-Krankenhaus St. Josef-Klinik für Urologie ( Site 0404) 93053 Regensburg (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 09417823505» Ansprechpartner anzeigenUniversitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405) 01307 Dresden (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +49 351 458 4425» Ansprechpartner anzeigen
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102) 32804 Orlando United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 205-520-6512» Ansprechpartner anzeigenFox Chase Cancer Center ( Site 0106) 19111 Philadelphia United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 215-728-3889» Ansprechpartner anzeigenMacquarie University-MQ Health Clinical Trials Unit ( Site 1803) 2109 Macquarie University AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 0402856430» Ansprechpartner anzeigenOne Clinical Research ( Site 1807) 6009 Nedlands AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61862799466» Ansprechpartner anzeigenCentre Hospitalier de l'Université de Montréal ( Site 0005) H2X 3E4 Montréal CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 5148908000» Ansprechpartner anzeigenCentre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 G1J 1Z4 Quebec City CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 4185254444» Ansprechpartner anzeigenCentre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer J1H 5H3 Sherbrooke CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 819-346-1110 ext. 13446» Ansprechpartner anzeigenFALP ( Site 1500) 7500921 Santiago ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 56956075934» Ansprechpartner anzeigenPontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1503) 8330032 Santiago ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 56942477513» Ansprechpartner anzeigenBradfordhill-Clinical Area ( Site 1501) 8420383 Santiago ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 56998744662» Ansprechpartner anzeigenONCOCENTRO APYS-ACEREY ( Site 1506) 2520598 Viña del Mar ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +56992369820» Ansprechpartner anzeigenInstitut de Cancérologie de l'Ouest ( Site 0300) 49055 ANGERS cedex 02 FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 33241352734» Ansprechpartner anzeigenGustave Roussy ( Site 0303) 94805 Villejuif FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 33142115348» Ansprechpartner anzeigenHôpital Saint-Louis ( Site 0304) 75475 Paris FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +33633211534» Ansprechpartner anzeigenFondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504) 00168 Roma ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 390458128116» Ansprechpartner anzeigenOspedale San Martino-U.O. Oncologia Medica 1 ( Site 0500) 16132 Genova ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 390105553303» Ansprechpartner anzeigenFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502) 20133 Milan ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 0390372405242» Ansprechpartner anzeigenOspedale San Raffaele-Oncologia Medica ( Site 0501) 20132 Milano ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 390226435789» Ansprechpartner anzeigenAuckland City Hospital ( Site 1901) 1023 Auckland New ZealandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 6493074949» Ansprechpartner anzeigenCentrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801) 85-796 Bydgoszcz PolandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 48501446778» Ansprechpartner anzeigenClinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805) WLK 61-731 Poznan PolandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 607075929» Ansprechpartner anzeigenSzpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802) 75-581 Koszalin PolandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 943488930» Ansprechpartner anzeigenHospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006) 08916 Badalona SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 34934978925» Ansprechpartner anzeigenHospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005) 28034 Madrid SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +34913368263» Ansprechpartner anzeigenHOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003) 28223 Pozuelo de Alarcon SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +34914521987» Ansprechpartner anzeigenHospital Universitari Vall d'Hebron-Oncology ( Site 1002) 08035 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +34934894350» Ansprechpartner anzeigenHOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001) 41013 Sevilla SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +34955012000» Ansprechpartner anzeigenKarolinska Universitetssjukhuset Solna ( Site 1101) 171 64 Stockholm SwedenRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 46851770000» Ansprechpartner anzeigenAkademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102) 751 85 Uppsala SwedenRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +46736869248» Ansprechpartner anzeigen
1. Disease Free Survival (DFS) (Time Frame - Up to approximately 28 months): DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease in the urothelial tract (upper tract or lower tract) or high grade T1 disease in the upper tract on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for each arm.
Secondary outcome:
1. Overall Survival (OS) (Time Frame - Up to approximately 28 months): Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for each arm.
2. Distant Metastasis-Free Survival (DMFS) (Time Frame - Up to approximately 28 months): DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for each arm.
3. Number of Participants Who Experience an Adverse Event (AE) (Time Frame - Up to approximately 16 months): An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience AEs will be reported for each arm.
4. Number of Participants Who Discontinue Study Treatment Due to an AE (Time Frame - Up to approximately 13 months): An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an adverse event will be presented. The number of participants who discontinue study treatment due to an AE will be reported for each arm.
Experimental: Pembrolizumab + V940 Participants receive 400 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of every 6-week cycle for up to 9 cycles, plus 1 mg of V940 via intramuscular (IM) injection once available every 3 weeks up to a total of 9 doses. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Active Comparator: Pembrolizumab + Placebo Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle for up to 9 cycles. Placebo will be administered every 3 weeks up to a total of 9 doses. The total duration of treatment is up to approximately 13 months.