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Active (not recruiting) Phase 2 NCT05327530

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

Phase 2 – studying effectiveness and dosage
Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

Sponsor: EMD Serono Research & Development Institute, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Avelumab
DRUG
Sacituzumab Govitecan
DRUG
M6223
DRUG
NKTR-255
DRUG
Locations 97
Australia (8)
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
Belgium (8)
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
Canada (4)
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
France (15)
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
Hôpital Foch - Service d'Oncologie Médicale
Suresnes , Hauts De Seine
Germany (8)
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
Essen
Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2
Frankfurt
Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie
Halle , Saxony-Anhalt
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
Halle
Kliniken Maria Hilf GmbH - Klinik fuer Urologie
Mönchengladbach
Kliniken Maria Hilf GmbH - Klinik fuer Urologie
Muenchen , North Rhine-Westphalia
Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
Münster
Universitaetsklinikum Tuebingen - Klinik fuer Urologie
Tübingen
Greece (4)
Athens Medical Center
Athens
General Hospital of Athens "Alexandra"
Athens
University General Hospital "Attikon"
Athens
Euromedica General Clinic of Thessaloniki
Thessaloniki
Italy (14)
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
Naples
Istituto Nazionale Tumori Regina Elena IRCCS - Urologia
Naples
IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
Padova
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
South Korea (8)
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
Spain (10)
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
Taiwan (7)
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
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital,Linkou
Taoyuan District
United Kingdom (3)
Barts Hospital - Dept of Medical Oncology
London , Greater London
The Christie Hospital - Dept of Oncology
Manchester
Royal Preston Hospital - Rosemere Cancer Centre
Preston
United States (8)
Johns Hopkins University
Baltimore , Maryland
The Johns Hopkins Hospital
Baltimore , Maryland
Beacon Cancer Care
Coeur d'Alene , Idaho
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
Kansas City , Kansas
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
Kansas City , Missouri
University of Wisconsin Cancer Center
Madison , Wisconsin
Seattle Cancer Care Alliance
Seattle , Washington
Multicare Health System Tacoma General Hospital
Tacoma , Washington
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.08.2022
Completion date
25.06.2026
Registry ID
NCT05327530
Source
clinicaltrials.gov
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