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

April 23, 2026 updated by: EMD Serono Research & Development Institute, Inc.

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia
        • Flinders Medical Centre
      • Footscray, Australia
        • Sunshine Hospital - PARENT
      • Kurralta Park, Australia
        • Ashford Cancer Centre Research
      • Liverpool, Australia
        • Liverpool Hospital - PARENT
      • Newcastle, Australia
        • Calvary Mater Newcastle - PARENT
      • Southport, Australia
        • Tasman Oncology Research Ltd - Oncology
      • Sydney, Australia
        • Macquarie University Hospital - PARENT
      • Westmead, Australia
        • The Kinghorn Can Cen
  • Belgium
      • Antwerp, Belgium
        • ZNA Middelheim - Middelheim - account 2
      • Brasschaat, Belgium
        • AZ Klina - PARENT
      • Brussels, Belgium
        • Institut Jules Bordet - Medical Oncology
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent - Medical Oncology
      • Kortrijk, Belgium
        • AZ Groeninge - Campus Kennedylaan - account 2
      • Libramont, Belgium
        • Centre Hospitalier de l'Ardenne - PARENT
      • Liège, Belgium
        • CHU de Liège - PARENT
      • Wuerzburg, Belgium
        • Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
  • Canada
      • Brampton, Canada
        • William Osler Health System - Brampton Civic Hospital
      • Greenfield Park, Canada
        • CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
      • Montreal, Canada
        • CHUM Centre de Recherche
      • Ottawa, Canada
        • The Ottawa Hospital Cancer Centre
  • France
      • Angers, France
        • ICO - Site Paul Papin - service d'oncologie medicale
      • Bordeaux, France
        • INSTITUT BERGONIE - Service d'Oncologie Médicale
      • Caen, France
        • Centre François Baclesse - Pathologies Gynecologiques
      • Créteil, France
        • Hôpital Henri Mondor - Service d'Oncologie Médicale
      • Le Mans, France
        • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical
      • Lyon, France
        • Centre Leon Berard - Service d'Oncologie Medicale
      • Marseille, France
        • Hôpital de la Timone - service d'urologie
      • Nîmes, France
        • Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale
      • Paris, France
        • Hôpital Cochin - Hematologie et Oncologie Médicale
      • Poitiers, France
        • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
      • Rennes, France
        • CRLCC Eugene Marquis - Service d'Oncologie médicale
      • Saint-Herblain, France
        • ICO - Site René Gauducheau - Service d'Oncologie medicale
      • Strasbourg, France
        • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
      • Strasbourg, France
        • Clinique Sainte-Anne - Service d'Oncologie Médicale
    • Hauts De Seine
      • Suresnes, Hauts De Seine, France, 92151
        • Hôpital Foch - Service d'Oncologie Médicale
  • Germany
      • Essen, Germany
        • Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
      • Frankfurt, Germany
        • Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2
      • Halle, Germany
        • Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
      • Mönchengladbach, Germany
        • Kliniken Maria Hilf GmbH - Klinik fuer Urologie
      • Münster, Germany
        • Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
      • Tübingen, Germany
        • Universitaetsklinikum Tuebingen - Klinik fuer Urologie
    • North Rhine-Westphalia
      • Muenchen, North Rhine-Westphalia, Germany, 41063
        • Kliniken Maria Hilf GmbH - Klinik fuer Urologie
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 0044384
        • Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie
  • Greece
      • Athens, Greece
        • General Hospital of Athens "Alexandra"
      • Athens, Greece
        • University General Hospital "Attikon"
      • Athens, Greece
        • Athens Medical Center
      • Thessaloniki, Greece
        • Euromedica General Clinic of Thessaloniki
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
      • Florence, Italy
        • Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
      • Forlì, Italy
        • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia
      • Milan, Italy
        • Ospedale San Raffaele - U.O. di Oncologia Medica
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria
      • Misterbianco, Italy
        • Humanitas Istituto Clinico Catanese - Oncologia Medica
      • Naples, Italy
        • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
      • Naples, Italy
        • Istituto Nazionale Tumori Regina Elena IRCCS - Urologia
      • Padova, Italy
        • IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia
      • Ravenna, Italy
        • Ospedale Santa Maria delle Croci
      • Rome, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
      • San Giovanni Rotondo, Italy
        • IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica
      • Terni, Italy
        • Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica
  • South Korea
      • Daejeon, South Korea
        • Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
      • Gyeonggi-do, South Korea
        • National Cancer Center
      • Seongnam-si, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, 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
  • Spain
      • Badajoz, Spain
        • Hospital Infanta Cristina - Unidad de Fase I
      • Barcelona, Spain
        • Hospital del Mar - Servicio de Oncologia
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau - Dept of Oncology
      • Barcelona, Spain
        • Hospital Clinic de Barcelona - Servicio de Oncologia
      • Barcelona, Spain
        • Hospital Universitario Virgen del Rocio - Oncology Service
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia - Dept of Oncology
      • Elche, Spain
        • Hospital General Universitario de Elche - Servicio de Oncologia
      • Lugo, Spain
        • Hospital Universitario Lucus Augusti - Oncology
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
      • Manresa, Spain
        • ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • Chi Mei Hospital, Liouying
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan
        • Chang Gung Memorial Hospital,Linkou
  • United Kingdom
      • Manchester, United Kingdom
        • The Christie Hospital - Dept of Oncology
      • Preston, United Kingdom
        • Royal Preston Hospital - Rosemere Cancer Centre
    • Greater London
      • London, Greater London, United Kingdom, 0024514
        • Barts Hospital - Dept of Medical Oncology
  • United States
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Beacon Cancer Care
    • Kansas
      • Kansas City, Kansas, United States, 66205
        • University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21287-7049
        • Johns Hopkins University
    • Missouri
      • Kansas City, Missouri, United States, 66204
        • AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Tacoma, Washington, United States, 98405
        • Multicare Health System Tacoma General Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Avelumab
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.
Other Names:
  • MSB0010718C
Experimental: Group B: Avelumab + Sacituzumab Govitecan
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.
Other Names:
  • MSB0010718C
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.
Other Names:
  • IMMU-132
  • GS-0132
  • Trodelvy™
Experimental: Group C: Avelumab + M6223
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.
Other Names:
  • MSB0010718C
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.
Experimental: Group D: Avelumab + NKTR-255
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.
Other Names:
  • MSB0010718C
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame: Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months
Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months
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]
Time Frame: From Randomization up to the last safety follow-up visit at approximately up to 51 months
From Randomization up to the last safety follow-up visit at approximately up to 51 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Time from randomization of study drug until death, assessed approximately up to 51 months
Time from randomization of study drug until death, assessed approximately up to 51 months
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Time Frame: Time from randomization of study drug up to 51 months
Time from randomization of study drug up to 51 months
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Time Frame: Time from first documented objective response to PD or death due to any cause, assessed approximately up to 51 months
Time from first documented objective response to PD or death due to any cause, assessed approximately up to 51 months
Pharmacokinetic Serum Concentration of Avelumab, M6223, Sacituzumab govitecan and NKTR255
Time Frame: Pre-dose up to safety follow up, assessed approximately up to maximum 51 months
Pre-dose up to safety follow up, assessed approximately up to maximum 51 months
Number of Participants with Positive Anti-Drug Antibody (ADA) of Avelumab, M6223, Sacituzumab govitecan and NKTR-255
Time Frame: Baseline up to 51 months
Baseline up to 51 months
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
Time Frame: Baseline, Week 13
Baseline, Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

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

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Actual)

June 20, 2025

Study Completion (Estimated)

June 25, 2026

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS100070_0119
  • 2021-003669-36 (EudraCT Number)
  • 2023-510139-12-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced or Metastatic Urothelial Carcinoma

Clinical Trials on Avelumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe