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ACTIVE NOT RECRUITING
NCT05327530
PHASE2

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.

View on ClinicalTrials.gov

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

2026-06-25

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

Avelumab

Participants will receive avelumab intravenous infusion at a dose of 800 milligrams (mg) once every 2 weeks (Q2W) until unacceptable toxicity, withdraw consent or initiation of a new treatment.

DRUG

Sacituzumab Govitecan

Participants will receive sacituzumab govitecan intravenous infusion at dose of 10 milligrams per kilogram (mg/kg) of body weight once a week (Q1W) on Day 1 and 8 of 21-day treatment cycles, in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.

DRUG

M6223

Participants will receive M6223 (anti-T cell-immuno-receptor with Ig and ITM domains \[anti-TIGIT\]) intravenous infusion at dose of 1600 mg Q2W in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.

DRUG

NKTR-255

Participants will receive NKTR-255 intravenous infusion at a dose of 3 micrograms per kilogram body weight (mcg/kg) once every 4 weeks (Q4W) in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.

Locations (97)

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 District, Taiwan

Barts Hospital - Dept of Medical Oncology

London, Greater London, United Kingdom

The Christie Hospital - Dept of Oncology

Manchester, United Kingdom

Royal Preston Hospital - Rosemere Cancer Centre

Preston, United Kingdom