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A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
Sponsor: EMD Serono Research & Development Institute, Inc.
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
256
Start Date
2022-08-17
Completion Date
2027-01-22
Last Updated
2026-09-28
Healthy Volunteers
No
Interventions
Avelumab
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
Sacituzumab Govitecan (SG)
Participants received intravenous infusion SG at dose of 10 mg/kg of bodyweight once a week on Day 1 and 8 of each 21-daytreatment cycles until unacceptable toxicity, withdraw consent or initiation of a new treatment.
M6223
Participants intravenous infusion of M6223 at dose of 1600 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
NKTR-255
Participants intravenous infusion of NKTR-255 at a dose of 3 mcg/kg of body weight once every 4 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
JB100
As per the Clinical Study Protocol, the control group (avelumab alone) was extended by data from an external control, i.e. the JAVELIN Bladder 100 study (JB100) (NCT02603432). Participants received an intravenous infusion of 10 mg/kg of Avelumab along with best supportive care (BSC), on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered asper the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anticancer therapy.
Locations (98)
Beacon Cancer Care
Coeur d'Alene, Idaho, 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
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
Sunshine Hospital - PARENT
Footscray, 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
Macquarie University Hospital - PARENT
Sydney, Australia
The Kinghorn Can Cen
Westmead, Australia
ZNA Middelheim - Middelheim - account 2
Antwerp, Belgium
AZ Klina - PARENT
Brasschaat, Belgium
Institut Jules Bordet - Medical Oncology
Brussels, Belgium
Universitair Ziekenhuis Gent - Medical Oncology
Ghent, Belgium
AZ Groeninge - Campus Kennedylaan - account 2
Kortrijk, Belgium
Centre Hospitalier de l'Ardenne - PARENT
Libramont, Belgium
CHU de Liège - PARENT
Liège, 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
Hôpital Foch - Service d'Oncologie Médicale
Suresnes, Hauts De Seine, France
ICO - Site Paul Papin - service d'oncologie medicale
Angers, France
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux, France
Centre François Baclesse - Pathologies Gynecologiques
Caen, France
Hôpital Henri Mondor - Service d'Oncologie Médicale
Créteil, 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, 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, France
CRLCC Eugene Marquis - Service d'Oncologie médicale
Rennes, France
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain, 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, North Rhine-Westphalia, Germany
Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie
Halle, Saxony-Anhalt, 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
Kliniken Maria Hilf GmbH - Klinik fuer Urologie
Mönchengladbach, Germany
Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
Münster, Germany
Universitaetsklinikum Tuebingen - Klinik fuer Urologie
Tübingen, 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
Florence, Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia
Forlì, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria
Milan, Italy
Ospedale San Raffaele - U.O. di Oncologia Medica
Milan, Italy
Humanitas Istituto Clinico Catanese - Oncologia Medica
Misterbianco, Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
Naples, Italy
Istituto Nazionale Tumori Regina Elena IRCCS - Urologia
Naples, 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
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, South Korea
National Cancer Center
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
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
Córdoba, 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
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, Taiwan
Barts Hospital - Dept of Medical Oncology
London, Greater London, United Kingdom
The Christie Hospital - Dept of Oncology
Manchester, United Kingdom
Lister Hospital - Dept of Oncology
Northwood, United Kingdom
Royal Preston Hospital - Rosemere Cancer Centre
Preston, United Kingdom