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Brief Title: A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)
Official Title: A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
Study ID: NCT06305767
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102), Orlando, Florida, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803), Macquarie University, New South Wales, Australia
One Clinical Research ( Site 1807), Nedlands, Western Australia, Australia
Centre Hospitalier de l'Université de Montréal ( Site 0005), Montréal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Quebec City, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer, Sherbrooke, Quebec, Canada
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1503), Santiago, Region M. De Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 1506), Viña del Mar, Valparaiso, Chile
Institut de Cancérologie de l'Ouest ( Site 0300), ANGERS cedex 02, Maine-et-Loire, France
Gustave Roussy ( Site 0303), Villejuif, Val-de-Marne, France
Hôpital Saint-Louis ( Site 0304), Paris, , France
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit, Munich, Bayern, Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504), Roma, Lazio, Italy
Auckland City Hospital ( Site 1901), Auckland, , New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801), Bydgoszcz, Kujawsko-pomorskie, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802), Koszalin, Zachodniopomorskie, Poland
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006), Badalona, Barcelona, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005), Madrid, Madrid, Comunidad De, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003), Pozuelo de Alarcon, Madrid, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1002), Barcelona, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001), Sevilla, , Spain
Karolinska Universitetssjukhuset Solna ( Site 1101), Stockholm, Stockholms Lan, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102), Uppsala, Uppsala Lan, Sweden
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR