English Español
Back to Clinical Trials

Brief Title: Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

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)

INTRODUCTION

  • Org Study ID: MS100070_0119
  • Secondary ID: 2021-003669-36
  • NTC ID: NCT05327530
  • Sponsor: EMD Serono Research & Development Institute, Inc.
Trial Awareness and Transparency website, US Medical Information website, Medical Resources

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    August 17, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

Primary Outcome 1 - Timeframe: Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months

Primary Outcome 2 - Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs) as per Qualitative Toxicity Scale [National Cancer Institute-Common Terminology Criteria for Adverse Events 5.0]

Primary Outcome 2 - Timeframe: From Randomization up to the last safety follow-up visit at approximately up to 51 months

CONDITION

  • Locally Advanced or Metastatic Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Responsible

Role: Study Director

Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Overall Contact

Name: Medical Responsible

Phone: 888-275-7376, +49 6151 72 5200

Email: eMediUSA@emdserono.com, service@emdgroup.com

LOCATION

Facility Status Contact
Facility: Beacon Cancer Care
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: Contact
Jaswinder J Singh

drjsingh@mac.com
Facility: 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
Status: Recruiting Contact: Principal Investigator
Christos Kyriakopoulos

ckyriako@medicine.wisc.edu
Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Shirley Wong

shirley.wong@mh.org.au
Facility: Multicare Health System Tacoma General Hospital
Tacoma, Washington 98405
United States
Status: Recruiting Contact: Principal Investigator
Andrew J Weickhardt

andrew.weickhardt@austin.org.au
Facility: University of Wisconsin Cancer Center
Madison, Wisconsin 53706
United States
Status: Recruiting Contact: Contact
Francis X Parnis

francis.parnis@icon.team
Facility: Flinders Medical Centre
Bedford Park,
Australia
Status: Recruiting Contact: Principal Investigator
Wei Chua

wei.chua@health.nsw.gov.au
Facility: Monash Medical Centre Clayton
Clayton,
Australia
Status: Recruiting Contact: Contact
James Lynam

james.lynam@calvarymater.org.au
Facility: Sunshine Hospital - PARENT
Footscray,
Australia
Status: Recruiting Contact: Principal Investigator
Andrew G Hill

andrew.hill@tasmanhealthcare.com.au
Facility: Austin Health
Heidelberg,
Australia
Status: Recruiting Contact: Contact
Alexander Guminski

alexander.guminski@health.nsw.gov.au
Facility: Ashford Cancer Centre Research
Kurralta Park,
Australia
Status: Recruiting Contact: Principal Investigator
Alison Y Zhang

alison.zhang@mqhealth.org.au
Facility: Liverpool Hospital - PARENT
Liverpool,
Australia
Status: Recruiting Contact: Contact
Megan Crumbaker

megan.crumbaker@svha.org.au
Facility: Calvary Mater Newcastle - PARENT
Newcastle,
Australia
Status: Recruiting Contact: Principal Investigator
Wesley Teurfs

wesley.teurfs@zna.be
Facility: Tasman Oncology Research Ltd - Oncology
Southport,
Australia
Status: Recruiting Contact: Contact
Wim Demey

wim.demey@klina.be
Facility: Royal North Shore Hospital - PARENT
St Leonards,
Australia
Status: Recruiting Contact: Principal Investigator
Nieves Martinez Chanza

nieves.martinez-chanza@bordet.be
Facility: Macquarie University Hospital - PARENT
Sydney,
Australia
Status: Recruiting Contact: Contact
Sylvie Rottey

sylvie.rottey@ugent.be
Facility: St Vincent's Hospital Sydney - PARENT
Westmead,
Australia
Status: Recruiting Contact: Principal Investigator
Philip Debruyne

philip.debruyne@azgroeninge.be
Facility: ZNA Middelheim - Middelheim - account 2
Antwerpen,
Belgium
Status: Recruiting Contact: Contact
Frederic Forget

frederic.forget@vivalia.be
Facility: AZ Klina - PARENT
Brasschaat,
Belgium
Status: Recruiting Contact: Principal Investigator
Marco Iafolla

catherine.sperlich@gmail.com
Facility: Institut Jules Bordet - Medical Oncology
Bruxelles,
Belgium
Status: Recruiting Contact: Contact
Catherine Sperlich

normand.blais.med@ssss.gouv.qc.ca
Facility: Universitair Ziekenhuis Gent - Medical Oncology
Gent,
Belgium
Status: Recruiting Contact: Principal Investigator
Normand Blais

ccanil@ottawahospital.on.ca
Facility: AZ Groeninge - Campus Kennedylaan - account 2
Kortrijk,
Belgium
Status: Recruiting Contact: Contact
Christina M Canil

doy@regionsjaelland.dk
Facility: Centre Hospitalier de l'Ardenne - PARENT
Libramont-Chevigny,
Belgium
Status: Recruiting Contact: Principal Investigator
Dorthe Yakymenko

andreascarus@rn.dk
Facility: William Osler Health System - Brampton Civic Hospital
Brampton,
Canada
Status: Recruiting Contact: Contact
Andreas Carus

viktor.gruenwald@uk-essen.de
Facility: CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
Greenfield Park,
Canada
Status: Recruiting Contact: Principal Investigator
Viktor Gruenwald

severine.banek@kgu.de
Facility: CHUM Centre de Recherche
Montreal,
Canada
Status: Recruiting Contact: Contact
Severine Banek

direktor.urologie@uk-halle.de
Facility: The Ottawa Hospital Cancer Centre
Ottawa,
Canada
Status: Recruiting Contact: Principal Investigator
Georgios Gakis

katrin.schlack@ukmuenster.de
Facility: Sjællands University Hospital - PARENT (Næstved)
Naestved,
Denmark
Status: Recruiting Contact: Contact
Katrin Schlack

herbert.sperling@mariahilf.de
Facility: Ålborg Universitets Hospital - onkologisk afd
Åalborg,
Denmark
Status: Recruiting Contact: Principal Investigator
Herbert Sperling

j.bedke@klinikum-stuttgart.de
Facility: Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
Essen,
Germany
Status: Recruiting Contact: Contact
Jens Bedke

tsiatas@hotmail.com
Facility: Klinikum der Johann Wolfgang Goethe-Universitaet - Urologie und Kinderurologie
Frankfurt,
Germany
Status: Recruiting Contact: Principal Investigator
Marinos Tsiatas

florazagouri@yahoo.co.uk
Facility: Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
Halle,
Germany
Status: Recruiting Contact: Contact
Flora Zagouri

abamias@med.uoa.gr
Facility: Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
Muenster,
Germany
Status: Recruiting Contact: Principal Investigator
Aristotelis Bamias

l.kontovinis@oncomedicare.com
Facility: Kliniken Maria Hilf GmbH - Klinik fuer Urologie
Mönchengladbach,
Germany
Status: Recruiting Contact: Contact
Loukas Kontovinis

francesco.massari@aosp.bo.it
Facility: Universitaetsklinikum Tuebingen - Klinik fuer Urologie
Stuttgart,
Germany
Status: Recruiting Contact: Principal Investigator
Francesco Massari

michele.caruso@ccocatania.it
Facility: Athens Medical Center
Athens,
Greece
Status: Recruiting Contact: Contact
Michele Caruso

r.tambaro@istitutotumori.na.it
Facility: General Hospital of Athens "Alexandra"
Athens,
Greece
Status: Recruiting Contact: Principal Investigator
Rosa Tambaro

marco.maruzzo@iov.veneto.it
Facility: University General Hospital "Attikon"
Haidari,
Greece
Status: Recruiting Contact: Contact
Marco Maruzzo

studiclinicisc.fcalabro@gmail.com
Facility: Euromedica General Clinic of Thessaloniki
Thessaloniki,
Greece
Status: Recruiting Contact: Principal Investigator
Fabio Calabro

e.maiello@operapadrepio.it
Facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
Bologna,
Italy
Status: Recruiting Contact: Principal Investigator
Evaristo Maiello

s.bracarda@aospterni.it
Facility: Humanitas Istituto Clinico Catanese - Oncologia Medica
Misterbianco,
Italy
Status: Recruiting Contact: Contact
Sergio Bracarda

cymed@cnuh.co.kr
Facility: Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
Napoli,
Italy
Status: Recruiting Contact: Principal Investigator
Hyo Jin Lee

sehyunkim@snubh.org
Facility: IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
Padova,
Italy
Status: Recruiting Contact: Contact
SE HYUN KIM

jaelyun@amc.seoul.kr
Facility: Azienda Ospedaliera San Camillo Forlanini - Dipartimento di Oncologia Medica
Roma,
Italy
Status: Recruiting Contact: Principal Investigator
Jae Lyun Lee

sh1767.park@samsung.com
Facility: IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica
San Giovanni Rotondo,
Italy
Status: Recruiting Contact: Contact
Se Hoon Park

misokim@snu.ac.kr
Facility: Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica
Terni,
Italy
Status: Recruiting Contact: Principal Investigator
Miso Kim

ssj338@yuhs.ac
Facility: Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
Daejeon,
Korea, Republic of
Status: Recruiting Contact: Contact
Sang Joon Shin

ihkmd@catholic.ac.kr
Facility: Seoul National University Bundang Hospital
Seongnam-si,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
In Ho Kim

martagcordero@gmail.com
Facility: Asan Medical Center
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Marta Gonzalez Cordero

maroto@santpau.es
Facility: Samsung Medical Center
Seoul,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Jose Pablo Maroto Rey

arodriguezvida@parcdesalutmar.cat
Facility: Seoul National University Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Alejo Rodriguez- Vida

oreig@clinic.cat
Facility: Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Oscar Reig Torras

mjosemv@yahoo.es
Facility: The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Maria Jose Mendez Vidal

fvazquez.md@gmail.com
Facility: Hospital Infanta Cristina - Unidad de Fase I
Badajoz,
Spain
Status: Recruiting Contact: Principal Investigator
Federico Vazquez Mazon

sergio.vazquez.estevez@sergas.es
Facility: Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona,
Spain
Status: Recruiting Contact: Contact
Sergio Vazquez Estevez

jaarranz@mdanderson.es
Facility: Hospital de la Santa Creu i Sant Pau - Dept of Oncology
Barcelona,
Spain
Status: Recruiting Contact: Principal Investigator
Jose Angel Arranz Arija

mfigols@althaia.cat
Facility: Hospital del Mar - Servicio de Oncologia
Barcelona,
Spain
Status: Recruiting Contact: Contact
Mariona Figols Gorina

chirivella_isa@gva.es
Facility: Hospital Universitario Virgen del Rocio - Oncology Service
Barcelona,
Spain
Status: Recruiting Contact: Principal Investigator
Isabel Chirivella Gonzalez

yolisu@mac.com
Facility: Hospital Universitario Reina Sofia - Dept of Oncology
Cordoba,
Spain
Status: Recruiting Contact: Contact
Yu Li Su

shpihu@yahoo.com.tw
Facility: Hospital General Universitario de Elche - Servicio de Oncologia
Elche,
Spain
Status: Recruiting Contact: Principal Investigator
Shu- Pin Huang

wuhc@mail.cmuh.org.tw
Facility: Hospital Universitario Lucus Augusti - Oncology
Lugo,
Spain
Status: Recruiting Contact: Contact
Hsi- Chin Wu

kevin640209@yahoo.com.tw
Facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid,
Spain
Status: Recruiting Contact: Principal Investigator
Chien- Liang Li

ptchang@vghtpe.gov.tw
Facility: ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
Manresa,
Spain
Status: Recruiting Contact: Contact
Mu- Hsin Chang

yctsai1@ntu.edu.tw
Facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia,
Spain
Status: Recruiting Contact: Principal Investigator
Yu- Chieh Tsai

su6826@gmail.com
Facility: Kaohsiung Chang Gung Memorial Hospital
Kaohsiung,
Taiwan
Status: Recruiting Contact: Contact
Po- Jung Su

elisa.fontana@hcahealthcare.co.uk
Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung,
Taiwan
Status: Recruiting Contact: Principal Investigator
Elisa Fontana

alison.birtle@lthtr.nhs.uk
Facility: China Medical University Hospital
Taichung,
Taiwan
Status: Recruiting Contact: Contact
Alison Birtle

Facility: Chi Mei Hospital, Liouying
Tainan,
Taiwan
Status: Recruiting Contact: Principal Investigator


Facility: Taipei Veterans General Hospital
Taipei City,
Taiwan
Status: Recruiting Contact: Contact


Facility: National Taiwan University Hospital
Taipei,
Taiwan
Status: Recruiting Contact: Principal Investigator


Facility: Chang Gung Memorial Hospital,Linkou
Taoyuan,
Taiwan
Status: Recruiting Contact: Contact


Facility: Sarah Cannon Research Institute UK
London,
United Kingdom
Status: Recruiting Contact: Principal Investigator


Facility: Royal Preston Hospital - Rosemere Cancer Centre
Preston,
United Kingdom
Status: Recruiting Contact: Contact