230
Participants
Start Date
March 28, 2024
Primary Completion Date
April 23, 2027
Study Completion Date
October 20, 2031
Pembrolizumab
Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.
Intismeran autogene
Administered via intramuscular (IM) injection at a dose of 1 mg every 3 weeks for a total of up to 9 adjuvant doses for Adjuvant Cohort participants, or at a dose of 1 mg every 3 weeks for a total of up to 9 doses in the neoadjuvant and adjuvant periods for Perioperative Cohort participants.
Placebo
Intismeran autogene diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.
Enfortumab Vedotin
Administered via IV infusion at a dose of 1.25 mg/kg on Day 1 and Day 8 of every cycle for up to four 3-week neoadjuvant cycles and up to five 3-week adjuvant cycles for Perioperative Cohort participants.
Surgery (RC plus PLND)
Curative intent surgery (RC plus PLND) will be administered to all participants in the Perioperative Cohort and will be done in accordance with the American Urological Association/American Society for Radiation Oncology/American Society of Clinical Oncology/Society of Urologic Oncology guidelines. RC plus PLND will be performed within 6 weeks of the last dose of neoadjuvant intismeran autogene plus pembrolizumab plus EV treatment. Adjuvant intismeran autogene plus pembrolizumab plus EV treatment will begin within 8 weeks of completing RC plus PLND.
ACTIVE_NOT_RECRUITING
Auckland City Hospital ( Site 1901), Auckland
RECRUITING
Hospital Militar Central Luis Arias Schereiber ( Site 1700), Lima
RECRUITING
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803), Macquarie University
COMPLETED
Westmead Hospital ( Site 1802), Westmead
RECRUITING
Mater Misericordiae Limited ( Site 1808), South Brisbane
RECRUITING
One Clinical Research ( Site 1807), Nedlands
RECRUITING
Icahn School of Medicine at Mount Sinai ( Site 0101), New York
RECRUITING
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0400), Berlin
ACTIVE_NOT_RECRUITING
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1702), Lima
RECRUITING
Oncosalud ( Site 1701), Lima
RECRUITING
Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500), Genoa
RECRUITING
Fox Chase Cancer Center ( Site 0106), Philadelphia
RECRUITING
Ospedale San Raffaele-Oncologia Medica ( Site 0501), Milan
RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502), Milan
RECRUITING
Duke Cancer Institute ( Site 0107), Durham
RECRUITING
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005), Madrid
RECRUITING
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003), Pozuelo de Alarcón
ACTIVE_NOT_RECRUITING
Oncopole Claudius Regaud ( Site 0302), Toulouse
RECRUITING
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102), Orlando
RECRUITING
Koc Universitesi Hastanesi ( Site 1206), Istanbul
ACTIVE_NOT_RECRUITING
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1205), Istanbul
RECRUITING
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1202), Istanbul
ACTIVE_NOT_RECRUITING
Ege Universitesi Hastanesi-Medical Oncology ( Site 1203), Izmir
RECRUITING
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001), Seville
RECRUITING
Cleveland Clinic Main ( Site 0100), Cleveland
RECRUITING
Institut de Cancérologie de l'Ouest ( Site 0300), Angers
RECRUITING
University of Iowa ( Site 0110), Iowa City
ACTIVE_NOT_RECRUITING
Hopital Claude Huriez - CHU de Lille ( Site 0301), Lille
RECRUITING
University of Chicago Medical Center ( Site 0109), Chicago
RECRUITING
UT Southwestern Medical Center ( Site 0103), Dallas
RECRUITING
Hôpital Saint-Louis ( Site 0304), Paris
RECRUITING
Houston Methodist Hospital-Department of Urology ( Site 0111), Houston
RECRUITING
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli-UOSC Oncologia ( Site 0503), Naples
RECRUITING
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0401), Munich
RECRUITING
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104), Los Angeles
RECRUITING
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0404), Regensburg
ACTIVE_NOT_RECRUITING
Gustave Roussy ( Site 0303), Villejuif
ACTIVE_NOT_RECRUITING
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 1606), Bogota
RECRUITING
Clínica Universitaria Colombia ( Site 1600), Bogotá
RECRUITING
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1605), Valledupar
ACTIVE_NOT_RECRUITING
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 1608), Santiago de Cali
RECRUITING
ONCOCENTRO APYS-ACEREY ( Site 1506), Viña del Mar
RECRUITING
CIDO SpA ( Site 1509), Temuco
RECRUITING
FALP ( Site 1500), Santiago
RECRUITING
Pontificia Universidad Catolica de Chile ( Site 1503), Santiago
RECRUITING
Bradfordhill-Clinical Area ( Site 1501), Recoleta, Santiago
ACTIVE_NOT_RECRUITING
BC Cancer Vancouver ( Site 0004), Vancouver
RECRUITING
Princess Margaret Cancer Centre ( Site 0003), Toronto
RECRUITING
Centre Hospitalier de l'Université de Montréal ( Site 0005), Montreal
RECRUITING
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001), Québec
RECRUITING
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002), Sherbrooke
RECRUITING
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405), Dresden
RECRUITING
Universitätsklinikum Halle-Universitätsklinik und Poliklinik für Urologie ( Site 0402), Halle
RECRUITING
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504), Rome
ACTIVE_NOT_RECRUITING
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805), Poznan
ACTIVE_NOT_RECRUITING
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801), Bydgoszcz
RECRUITING
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 0800), Warsaw
ACTIVE_NOT_RECRUITING
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0802), Koszalin
RECRUITING
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0806), Kielce
ACTIVE_NOT_RECRUITING
Korea University Anam Hospital ( Site 2002), Seoul
ACTIVE_NOT_RECRUITING
Seoul National University Hospital-Urology ( Site 2000), Seoul
ACTIVE_NOT_RECRUITING
Samsung Medical Center-Urology ( Site 2001), Seoul
RECRUITING
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006), Badalona
RECRUITING
Hospital Universitari Vall d'Hebron-Oncology ( Site 1002), Barcelona
RECRUITING
Karolinska Universitetssjukhuset Solna ( Site 1101), Stockholm
ACTIVE_NOT_RECRUITING
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102), Uppsala
ACTIVE_NOT_RECRUITING
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1200), Ankara
ACTIVE_NOT_RECRUITING
Memorial Ankara Hastanesi-Medical Oncology ( Site 1204), Ankara
RECRUITING
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1201), Ankara
ACTIVE_NOT_RECRUITING
Torbay Hospital ( Site 1303), Torquay
ACTIVE_NOT_RECRUITING
Royal Free Hospital ( Site 1300), London
ACTIVE_NOT_RECRUITING
Gartnavel General Hospital-Clinical Trials Unit ( Site 1301), Glasgow
ACTIVE_NOT_RECRUITING
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1302), London
RECRUITING
The Christie NHS Foundation Trust ( Site 1306), Manchester
ModernaTX, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY