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A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005) 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.
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: Has muscle-invasive urothelial carcinoma (MIUC) Has dominant histology of UC Has high-risk pathologic disease after radical resection Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS) Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization Exclusion Criteria: Has received prior systemic anticancer therapy Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients Has current pneumonitis/interstitial lung disease Has active infection requiring systemic therapy Has active hepatitis B and hepatitis C virus infection
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There are 26 Locations for this study
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102) Orlando Florida, 32804, United States
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Fox Chase Cancer Center ( Site 0106) Philadelphia Pennsylvania, 19111, United States
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Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) Macquarie University New South Wales, 2109, Australia
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One Clinical Research ( Site 1807) Nedlands Western Australia, 6009, Australia
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Centre Hospitalier de l'Université de Montréal ( Site 0005) Montréal Quebec, H2X 3, Canada
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Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 Quebec City Quebec, G1J 1, Canada
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Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer Sherbrooke Quebec, J1H 5, Canada
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FALP ( Site 1500) Santiago Region M. De Santiago, 75009, Chile
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Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1503) Santiago Region M. De Santiago, 83300, Chile
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ONCOCENTRO APYS-ACEREY ( Site 1506) Viña del Mar Valparaiso, 25205, Chile
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Institut de Cancérologie de l'Ouest ( Site 0300) ANGERS cedex 02 Maine-et-Loire, 49055, France
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Gustave Roussy ( Site 0303) Villejuif Val-de-Marne, 94800, France
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Hôpital Saint-Louis ( Site 0304) Paris , 75475, France
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klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit Munich Bayern, 81675, Germany
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504) Roma Lazio, 00168, Italy
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Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500) Genova Liguria, 16132, Italy
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Auckland City Hospital ( Site 1901) Auckland , 1023, New Zealand
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Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801) Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
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Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802) Koszalin Zachodniopomorskie, 75-58, Poland
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Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006) Badalona Barcelona, 08916, Spain
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Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005) Madrid Madrid, Comunidad De, 28034, Spain
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HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003) Pozuelo de Alarcon Madrid, 28223, Spain
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Hospital Universitari Vall d'Hebron-Oncology ( Site 1002) Barcelona , 08035, Spain
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HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001) Sevilla , 41013, Spain
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Karolinska Universitetssjukhuset Solna ( Site 1101) Stockholm Stockholms Lan, 171 6, Sweden
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Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102) Uppsala Uppsala Lan, 751 8, Sweden
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