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Brief Title: A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
Official Title: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)
Study ID: NCT05327530
Brief Summary: The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beacon Cancer Care, Coeur d'Alene, Idaho, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN), Kansas City, Kansas, United States
Johns Hopkins University, Baltimore, Maryland, United States
The Johns Hopkins Hospital, Baltimore, Maryland, United States
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center, Kansas City, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Inova Schar Cancer Institute, Falls Church, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Multicare Health System Tacoma General Hospital, Tacoma, Washington, United States
University of Wisconsin Cancer Center, Madison, Wisconsin, United States
Flinders Medical Centre, Bedford Park, , Australia
Monash Medical Centre Clayton, Clayton, , Australia
Sunshine Hospital - PARENT, Footscray, , Australia
Austin Health, Heidelberg, , Australia
Ashford Cancer Centre Research, Kurralta Park, , Australia
Liverpool Hospital - PARENT, Liverpool, , Australia
Calvary Mater Newcastle - PARENT, Newcastle, , Australia
Tasman Oncology Research Ltd - Oncology, Southport, , Australia
Royal North Shore Hospital - PARENT, St Leonards, , Australia
Macquarie University Hospital - PARENT, Sydney, , Australia
The Kinghorn Can Cen, Westmead, , Australia
ZNA Middelheim - Middelheim - account 2, Antwerpen, , Belgium
AZ Klina - PARENT, Brasschaat, , Belgium
Institut Jules Bordet - Medical Oncology, Bruxelles, , Belgium
Universitair Ziekenhuis Gent - Medical Oncology, Gent, , Belgium
AZ Groeninge - Campus Kennedylaan - account 2, Kortrijk, , Belgium
Centre Hospitalier de l'Ardenne - PARENT, Libramont, , Belgium
CHU de Liège - PARENT, Liege, , Belgium
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie, Wuerzburg, , Belgium
William Osler Health System - Brampton Civic Hospital, Brampton, , Canada
CISSS de la Monteregie-Centre - Hospital Charles Le Moyne, Greenfield Park, , Canada
CHUM Centre de Recherche, Montreal, , Canada
The Ottawa Hospital Cancer Centre, Ottawa, , Canada
Sjællands University Hospital - PARENT (Næstved), Naestved, , Denmark
Ålborg Universitets Hospital - onkologisk afd, Åalborg, , Denmark
ICO - Site Paul Papin - service d'oncologie medicale, Angers cedex 2, , France
Institut Bergonié - Service d'Oncologie Médicale, Bordeaux Cedex, , France
Centre François Baclesse - Pathologies Gynecologiques, Caen CEDEX, , France
Hôpital Henri Mondor - Service d'Oncologie Médicale, Creteil, , France
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical, Le Mans, , France
Centre Leon Berard - Service d'Oncologie Medicale, Lyon, , France
Hôpital de la Timone - service d'urologie, Marseille Cedex 5, , France
Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale, Nîmes, , France
Hôpital Cochin - Hematologie et Oncologie Médicale, Paris, , France
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale, Poitiers Cedex, , France
CRLCC Eugene Marquis - Service d'Oncologie médicale, Rennes cedex, , France
ICO - Site René Gauducheau - Service d'Oncologie medicale, SAINT-HERBLAIN Cedex, , France
Clinique Sainte-Anne - Service d'Oncologie Médicale, Strasbourg, , France
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale, Strasbourg, , France
Kliniken Maria Hilf GmbH - Klinik fuer Urologie, Muenchen, Nordrhein Westfalen, Germany
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum, Essen, , Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2, Frankfurt, , Germany
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie, Halle, , Germany
Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie, Muenster, , Germany
Kliniken Maria Hilf GmbH - Klinik fuer Urologie, Mönchengladbach, , Germany
Universitaetsklinikum Tuebingen - Klinik fuer Urologie, Tuebingen, , Germany
Athens Medical Center, Athens, , Greece
General Hospital of Athens "Alexandra", Athens, , Greece
University General Hospital "Attikon", Athens, , Greece
Euromedica General Clinic of Thessaloniki, Thessaloniki, , Greece
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica, Bologna, , Italy
Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica, Firenze, , Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia, Forli, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria, Milano, , Italy
Ospedale San Raffaele - U.O. di Oncologia Medica, Milano, , Italy
Humanitas Istituto Clinico Catanese - Oncologia Medica, Misterbianco, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A, Napoli, , Italy
Istituto Nazionale Tumori Regina Elena IRCCS - Urologia, Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1, Padova, , Italy
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia, Pisa, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
Azienda Ospedaliera San Camillo Forlanini - Dipartimento di Oncologia Medica, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica, Rome, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica, San Giovanni Rotondo, , Italy
Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica, Terni, , Italy
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology), Daejeon, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Hospital Infanta Cristina - Unidad de Fase I, Badajoz, , Spain
Hospital Clinic de Barcelona - Servicio de Oncologia, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau - Dept of Oncology, Barcelona, , Spain
Hospital del Mar - Servicio de Oncologia, Barcelona, , Spain
Hospital Universitario Virgen del Rocio - Oncology Service, Barcelona, , Spain
Hospital Universitario Reina Sofia - Dept of Oncology, Cordoba, , Spain
Hospital General Universitario de Elche - Servicio de Oncologia, Elche, , Spain
Hospital Universitario Lucus Augusti - Oncology, Lugo, , Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica, Madrid, , Spain
ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept, Manresa, , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica, Valencia, , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica, Valencia, , Spain
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Chi Mei Hospital, Liouying, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital,Linkou, Taoyuan, , Taiwan
Sarah Cannon Research Institute UK, London, , United Kingdom
The Christie Hospital - Dept of Oncology, Manchester, , United Kingdom
Royal Preston Hospital - Rosemere Cancer Centre, Preston, , United Kingdom
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR