Bladder Cancer Clinical Trial

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology
Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy.
The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study
Estimated life expectancy of at least 3 months
Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Adequate hematological, hepatic, and renal function as defined in the protocol
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, anti-T-cell-immuno-receptor with Ig and ITM domains (anti-TIGIT) any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, agents targeting Nectin-4, or any of the investigational drugs used in combination with avelumab.
Participants with active infection 48 hours before randomization requiring systemic therapy
Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations
Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) administered >= 2 weeks prior first dose of study treatment. All severe acute respiratory syndrome coronavirus (SARS-CoV-2) vaccines approved or authorized by local Health Authorities are allowed
Other protocol defined exclusion criteria could apply

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

252

Study ID:

NCT05327530

Recruitment Status:

Recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 11 Locations for this study

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Beacon Cancer Care
Coeur d'Alene Idaho, 83814, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
Kansas City Kansas, 66205, United States More Info
Saqib Abbasi
Principal Investigator
Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Jean Hoffman Censits
Principal Investigator
The Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
Kansas City Missouri, 66204, United States More Info
Jaswinder J Singh
Principal Investigator
Washington University
Saint Louis Missouri, 63110, United States
Inova Schar Cancer Institute
Falls Church Virginia, 22042, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Petros Grivas
Principal Investigator
Multicare Health System Tacoma General Hospital
Tacoma Washington, 98405, United States More Info
Sunil Rangarajan
Principal Investigator
University of Wisconsin Cancer Center
Madison Wisconsin, 53706, United States More Info
Christos Kyriakopoulos
Principal Investigator
Flinders Medical Centre
Bedford Park , , Australia More Info
Ganessan Kichenadasse
Principal Investigator
Monash Medical Centre Clayton
Clayton , , Australia More Info
Cameron McLaren
Principal Investigator
Sunshine Hospital - PARENT
Footscray , , Australia More Info
Shirley Wong
Principal Investigator
Austin Health
Heidelberg , , Australia More Info
Andrew J Weickhardt
Principal Investigator
Ashford Cancer Centre Research
Kurralta Park , , Australia More Info
Annabel Smith
Principal Investigator
Liverpool Hospital - PARENT
Liverpool , , Australia More Info
Wei Chua
Principal Investigator
Calvary Mater Newcastle - PARENT
Newcastle , , Australia More Info
James Lynam
Principal Investigator
Tasman Oncology Research Ltd - Oncology
Southport , , Australia More Info
Andrew G Hill
Principal Investigator
Royal North Shore Hospital - PARENT
St Leonards , , Australia More Info
Alexander Guminski
Principal Investigator
Macquarie University Hospital - PARENT
Sydney , , Australia More Info
Alison Y Zhang
Principal Investigator
The Kinghorn Can Cen
Westmead , , Australia More Info
Megan Crumbaker
Principal Investigator
ZNA Middelheim - Middelheim - account 2
Antwerpen , , Belgium More Info
Wesley Teurfs
Principal Investigator
AZ Klina - PARENT
Brasschaat , , Belgium More Info
Wim Demey
Principal Investigator
Institut Jules Bordet - Medical Oncology
Bruxelles , , Belgium More Info
Nieves Martinez Chanza
Principal Investigator
Universitair Ziekenhuis Gent - Medical Oncology
Gent , , Belgium More Info
Sylvie Rottey
Principal Investigator
AZ Groeninge - Campus Kennedylaan - account 2
Kortrijk , , Belgium More Info
Philip Debruyne
Principal Investigator
Centre Hospitalier de l'Ardenne - PARENT
Libramont , , Belgium More Info
Frederic Forget
Principal Investigator
CHU de Liège - PARENT
Liege , , Belgium More Info
Pierre Freres
Principal Investigator
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
Wuerzburg , , Belgium More Info
Anna K Seitz
Principal Investigator
William Osler Health System - Brampton Civic Hospital
Brampton , , Canada More Info
Marco Iafolla
Principal Investigator
CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
Greenfield Park , , Canada More Info
Catherine Sperlich
Principal Investigator
CHUM Centre de Recherche
Montreal , , Canada More Info
Normand Blais
Principal Investigator
The Ottawa Hospital Cancer Centre
Ottawa , , Canada More Info
Christina M Canil
Principal Investigator
Sjællands University Hospital - PARENT (Næstved)
Naestved , , Denmark More Info
Dorthe Yakymenko
Principal Investigator
Ålborg Universitets Hospital - onkologisk afd
Åalborg , , Denmark More Info
Andreas Carus
Principal Investigator
ICO - Site Paul Papin - service d'oncologie medicale
Angers cedex 2 , , France More Info
Remy Delva
Principal Investigator
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux Cedex , , France More Info
Guilhem Roubaud
Principal Investigator
Centre François Baclesse - Pathologies Gynecologiques
Caen CEDEX , , France More Info
Elodie Coquan
Principal Investigator
Hôpital Henri Mondor - Service d'Oncologie Médicale
Creteil , , France More Info
Christophe Tournigand
Principal Investigator
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical
Le Mans , , France More Info
Eric Voog
Principal Investigator
Centre Leon Berard - Service d'Oncologie Medicale
Lyon , , France More Info
Aude Flechon
Principal Investigator
Hôpital de la Timone - service d'urologie
Marseille Cedex 5 , , France More Info
Jean Laurent Deville
Principal Investigator
Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale
Nîmes , , France More Info
Nadine Houede
Principal Investigator
Hôpital Cochin - Hematologie et Oncologie Médicale
Paris , , France More Info
Olivier Huillard
Principal Investigator
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers Cedex , , France More Info
Nicolas Isambert
Principal Investigator
CRLCC Eugene Marquis - Service d'Oncologie médicale
Rennes cedex , , France More Info
Brigitte Laguerre
Principal Investigator
ICO - Site René Gauducheau - Service d'Oncologie medicale
SAINT-HERBLAIN Cedex , , France More Info
Frederic Rolland
Principal Investigator
Clinique Sainte-Anne - Service d'Oncologie Médicale
Strasbourg , , France More Info
Louis Marie Dourthe
Principal Investigator
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
Strasbourg , , France More Info
Philippe Barthelemy
Principal Investigator
Kliniken Maria Hilf GmbH - Klinik fuer Urologie
Muenchen Nordrhein Westfalen, 41063, Germany More Info
Herbert Sperling
Principal Investigator
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
Essen , , Germany More Info
Viktor Gruenwald
Principal Investigator
Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2
Frankfurt , , Germany More Info
Severine Banek
Principal Investigator
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
Halle , , Germany More Info
Georgios Gakis
Principal Investigator
Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
Muenster , , Germany More Info
Katrin Schlack
Principal Investigator
Kliniken Maria Hilf GmbH - Klinik fuer Urologie
Mönchengladbach , , Germany More Info
Herbert Sperling
Principal Investigator
Universitaetsklinikum Tuebingen - Klinik fuer Urologie
Tuebingen , , Germany More Info
Rausch Steffen
Principal Investigator
Athens Medical Center
Athens , , Greece More Info
Marinos Tsiatas
Principal Investigator
General Hospital of Athens "Alexandra"
Athens , , Greece More Info
Flora Zagouri
Principal Investigator
University General Hospital "Attikon"
Athens , , Greece More Info
Aristotelis Bamias
Principal Investigator
Euromedica General Clinic of Thessaloniki
Thessaloniki , , Greece More Info
Loukas Kontovinis
Principal Investigator
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
Bologna , , Italy More Info
Francesco Massari
Principal Investigator
Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
Firenze , , Italy More Info
Lorenzo Antonuzzo
Principal Investigator
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia
Forli , , Italy More Info
Ugo De Giorgi
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria
Milano , , Italy More Info
Valentina Guadalupi
Principal Investigator
Ospedale San Raffaele - U.O. di Oncologia Medica
Milano , , Italy More Info
Andrea Necchi
Principal Investigator
Humanitas Istituto Clinico Catanese - Oncologia Medica
Misterbianco , , Italy More Info
Michele Caruso
Principal Investigator
Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
Napoli , , Italy More Info
Rosa Tambaro
Principal Investigator
Istituto Nazionale Tumori Regina Elena IRCCS - Urologia
Napoli , , Italy More Info
Fabio Calabro
Principal Investigator
IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
Padova , , Italy More Info
Marco Maruzzo
Principal Investigator
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia
Pisa , , Italy More Info
Luca Galli
Principal Investigator
Ospedale Santa Maria delle Croci
Ravenna , , Italy More Info
Francesco Carrozza
Principal Investigator
Azienda Ospedaliera San Camillo Forlanini - Dipartimento di Oncologia Medica
Roma , , Italy More Info
Linda Cerbone
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome , , Italy More Info
Giampaolo Tortora
Principal Investigator
IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica
San Giovanni Rotondo , , Italy More Info
Evaristo Maiello
Principal Investigator
Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica
Terni , , Italy More Info
Sergio Bracarda
Principal Investigator
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
Daejeon , , Korea, Republic of More Info
Hyo Jin Lee
Principal Investigator
National Cancer Center
Gyeonggi-do , , Korea, Republic of More Info
Ho Kyung Seo
Principal Investigator
Seoul National University Bundang Hospital
Seongnam-si , , Korea, Republic of More Info
SE HYUN KIM
Principal Investigator
Asan Medical Center
Seoul , , Korea, Republic of More Info
Jae Lyun Lee
Principal Investigator
Samsung Medical Center
Seoul , , Korea, Republic of More Info
Se Hoon Park
Principal Investigator
Seoul National University Hospital
Seoul , , Korea, Republic of More Info
Miso Kim
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of More Info
Sang Joon Shin
Principal Investigator
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , , Korea, Republic of More Info
In Ho Kim
Principal Investigator
Hospital Infanta Cristina - Unidad de Fase I
Badajoz , , Spain More Info
Marta Gonzalez Cordero
Principal Investigator
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona , , Spain More Info
Oscar Reig Torras
Principal Investigator
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
Barcelona , , Spain More Info
Jose Pablo Maroto Rey
Principal Investigator
Hospital del Mar - Servicio de Oncologia
Barcelona , , Spain More Info
Alejo Rodriguez-Vida
Principal Investigator
Hospital Universitario Virgen del Rocio - Oncology Service
Barcelona , , Spain More Info
Begona Perez Valderrama
Principal Investigator
Hospital Universitario Reina Sofia - Dept of Oncology
Cordoba , , Spain More Info
Maria Jose Mendez Vidal
Principal Investigator
Hospital General Universitario de Elche - Servicio de Oncologia
Elche , , Spain More Info
Federico Vazquez Mazon
Principal Investigator
Hospital Universitario Lucus Augusti - Oncology
Lugo , , Spain More Info
Sergio Vazquez Estevez
Principal Investigator
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid , , Spain More Info
Jose Angel Arranz Arija
Principal Investigator
ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
Manresa , , Spain More Info
Mariona Figols Gorina
Principal Investigator
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia , , Spain More Info
Isabel Chirivella Gonzalez
Principal Investigator
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia , , Spain More Info
Isabel Chirivella Gonzalez
Principal Investigator
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , , Taiwan More Info
Yu Li Su
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , , Taiwan More Info
Shu-Pin Huang
Principal Investigator
China Medical University Hospital
Taichung , , Taiwan More Info
Hsi-Chin Wu
Principal Investigator
Chi Mei Hospital, Liouying
Tainan , , Taiwan More Info
Chien-Liang Li
Principal Investigator
Taipei Veterans General Hospital
Taipei City , , Taiwan More Info
Mu-Hsin Chang
Principal Investigator
National Taiwan University Hospital
Taipei , , Taiwan More Info
Yu- Chieh Tsai
Principal Investigator
Chang Gung Memorial Hospital,Linkou
Taoyuan , , Taiwan More Info
Po-Jung Su
Principal Investigator
Sarah Cannon Research Institute UK
London , , United Kingdom More Info
Elisa Fontana
Principal Investigator
The Christie Hospital - Dept of Oncology
Manchester , , United Kingdom More Info
Yee Pei Song
Principal Investigator
Royal Preston Hospital - Rosemere Cancer Centre
Preston , , United Kingdom More Info
Alison Birtle
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

252

Study ID:

NCT05327530

Recruitment Status:

Recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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