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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

August 17, 2022

Primary Completion Date

June 20, 2025

Study Completion Date

June 25, 2026

Conditions
Locally Advanced or Metastatic Urothelial Carcinoma
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.

Trial Locations (97)

21287

The Johns Hopkins Hospital, Baltimore

41063

Kliniken Maria Hilf GmbH - Klinik fuer Urologie, Muenchen

53706

University of Wisconsin Cancer Center, Madison

66204

AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center, Kansas City

66205

University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN), Kansas City

83814

Beacon Cancer Care, Coeur d'Alene

92151

Hôpital Foch - Service d'Oncologie Médicale, Suresnes

98109

Seattle Cancer Care Alliance, Seattle

98405

Multicare Health System Tacoma General Hospital, Tacoma

21287-7049

Johns Hopkins University, Baltimore

Unknown

Flinders Medical Centre, Bedford Park

Sunshine Hospital - PARENT, Footscray

Ashford Cancer Centre Research, Kurralta Park

Liverpool Hospital - PARENT, Liverpool

Calvary Mater Newcastle - PARENT, Newcastle

Tasman Oncology Research Ltd - Oncology, Southport

Macquarie University Hospital - PARENT, Sydney

The Kinghorn Can Cen, Westmead

ZNA Middelheim - Middelheim - account 2, Antwerp

AZ Klina - PARENT, Brasschaat

Institut Jules Bordet - Medical Oncology, Brussels

Universitair Ziekenhuis Gent - Medical Oncology, Ghent

AZ Groeninge - Campus Kennedylaan - account 2, Kortrijk

Centre Hospitalier de l'Ardenne - PARENT, Libramont

CHU de Liège - PARENT, Liège

Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie, Wuerzburg

William Osler Health System - Brampton Civic Hospital, Brampton

CISSS de la Monteregie-Centre - Hospital Charles Le Moyne, Greenfield Park

CHUM Centre de Recherche, Montreal

The Ottawa Hospital Cancer Centre, Ottawa

ICO - Site Paul Papin - service d'oncologie medicale, Angers

Institut Bergonié - Service d'Oncologie Médicale, Bordeaux

Centre François Baclesse - Pathologies Gynecologiques, Caen

Hôpital Henri Mondor - Service d'Oncologie Médicale, Créteil

Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical, Le Mans

Centre Leon Berard - Service d'Oncologie Medicale, Lyon

Hôpital de la Timone - service d'urologie, Marseille

Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale, Nîmes

Hôpital Cochin - Hematologie et Oncologie Médicale, Paris

CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale, Poitiers

CRLCC Eugene Marquis - Service d'Oncologie médicale, Rennes

ICO - Site René Gauducheau - Service d'Oncologie medicale, Saint-Herblain

Clinique Sainte-Anne - Service d'Oncologie Médicale, Strasbourg

Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale, Strasbourg

Universitaetsklinikum Essen - Westdeutsches Tumorzentrum, Essen

Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2, Frankfurt

Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie, Halle

Kliniken Maria Hilf GmbH - Klinik fuer Urologie, Mönchengladbach

Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie, Münster

Universitaetsklinikum Tuebingen - Klinik fuer Urologie, Tübingen

Athens Medical Center, Athens

"General Hospital of Athens Alexandra", Athens

"University General Hospital Attikon", Athens

Euromedica General Clinic of Thessaloniki, Thessaloniki

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica, Bologna

Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica, Florence

"IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Dino Amadori - IRST - Oncologia", Forlì

Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria, Milan

Ospedale San Raffaele - U.O. di Oncologia Medica, Milan

Humanitas Istituto Clinico Catanese - Oncologia Medica, Misterbianco

Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A, Napoli

Istituto Nazionale Tumori Regina Elena IRCCS - Urologia, Napoli

IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1, Padua

Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia, Pisa

Ospedale Santa Maria delle Croci, Ravenna

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica, Rome

IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica, San Giovanni Rotondo

Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica, Terni

Chungnam National University Hospital - Department of Internal Medicine (Rheumatology), Daejeon

National Cancer Center, Gyeonggi-do

Seoul National University Bundang Hospital, Seongnam-si

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital, Yonsei University Health System, Seoul

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

Hospital Infanta Cristina - Unidad de Fase I, Badajoz

Hospital Clinic de Barcelona - Servicio de Oncologia, Barcelona

Hospital de la Santa Creu i Sant Pau - Dept of Oncology, Barcelona

Hospital del Mar - Servicio de Oncologia, Barcelona

Hospital Universitario Virgen del Rocio - Oncology Service, Barcelona

Hospital Universitario Reina Sofia - Dept of Oncology, Córdoba

Hospital General Universitario de Elche - Servicio de Oncologia, Elche

Hospital Universitario Lucus Augusti - Oncology, Lugo

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica, Madrid

ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept, Manresa

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

China Medical University Hospital, Taichung

Chi Mei Hospital, Liouying, Tainan City

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Chang Gung Memorial Hospital,Linkou, Taoyuan District

The Christie Hospital - Dept of Oncology, Manchester

Royal Preston Hospital - Rosemere Cancer Centre, Preston

0044384

Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie, Halle

0024514

Barts Hospital - Dept of Medical Oncology, London

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics

UNKNOWN

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY