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New combo therapy aims to keep bladder cancer at bay after chemo

NCT ID NCT05327530

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether adding avelumab (an immunotherapy) to another anti-cancer drug (sacituzumab govitecan) can help prevent advanced bladder cancer from growing after initial chemotherapy. About 256 participants with locally advanced or metastatic urothelial carcinoma whose disease did not worsen after first-line platinum chemo will receive the combination as maintenance treatment. The study measures how long the cancer stays controlled and monitors side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
avelumab (immunotherapy) combined with sacituzumab govitecan (chemotherapy)
What this could lead to
If successful, this could offer a new maintenance treatment option to help keep advanced bladder cancer from growing after initial chemotherapy.
What could go wrong
This is a mid-stage trial with only 256 participants, so results may not apply to everyone. Combination therapies can cause more side effects, and the study is not yet complete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

256 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic urothelial carcinoma

Contacts and locations

Locations

  • ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept

    Manresa, Spain

  • 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

  • AZ Groeninge - Campus Kennedylaan - account 2

    Kortrijk, Belgium

  • AZ Klina - PARENT

    Brasschaat, Belgium

  • Asan Medical Center

    Seoul, South Korea

  • Ashford Cancer Centre Research

    Kurralta Park, Australia

  • Athens Medical Center

    Athens, Greece

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

    Terni, Italy

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

    Florence, Italy

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

    Bologna, Italy

  • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia

    Pisa, Italy

  • Barts Hospital - Dept of Medical Oncology

    London, Greater London, 0024514, United Kingdom

  • Beacon Cancer Care

    Coeur d'Alene, Idaho, 83814, United States

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

    Poitiers, France

  • CHU de Liège - PARENT

    Liège, Belgium

  • CHUM Centre de Recherche

    Montreal, Canada

  • CISSS de la Monteregie-Centre - Hospital Charles Le Moyne

    Greenfield Park, Canada

  • CRLCC Eugene Marquis - Service d'Oncologie médicale

    Rennes, France

  • Calvary Mater Newcastle - PARENT

    Newcastle, Australia

  • Centre François Baclesse - Pathologies Gynecologiques

    Caen, France

  • Centre Hospitalier de l'Ardenne - PARENT

    Libramont, Belgium

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon, France

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

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

    Daejeon, South Korea

  • Clinique Sainte-Anne - Service d'Oncologie Médicale

    Strasbourg, France

  • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical

    Le Mans, France

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, Greece

  • Flinders Medical Centre

    Bedford Park, Australia

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

    Milan, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Rome, Italy

  • General Hospital of Athens "Alexandra"

    Athens, Greece

  • Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale

    Nîmes, France

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

    Madrid, Spain

  • Hospital General Universitario de Elche - Servicio de Oncologia

    Elche, Spain

  • Hospital Infanta Cristina - Unidad de Fase I

    Badajoz, Spain

  • Hospital Universitario Lucus Augusti - Oncology

    Lugo, Spain

  • Hospital Universitario Reina Sofia - Dept of Oncology

    Córdoba, Spain

  • Hospital Universitario Virgen del Rocio - Oncology Service

    Barcelona, Spain

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

    Barcelona, Spain

  • Hospital del Mar - Servicio de Oncologia

    Barcelona, Spain

  • Humanitas Istituto Clinico Catanese - Oncologia Medica

    Misterbianco, Italy

  • Hôpital Cochin - Hematologie et Oncologie Médicale

    Paris, France

  • Hôpital Foch - Service d'Oncologie Médicale

    Suresnes, Hauts De Seine, 92151, France

  • Hôpital Henri Mondor - Service d'Oncologie Médicale

    Créteil, France

  • Hôpital de la Timone - service d'urologie

    Marseille, France

  • ICO - Site Paul Papin - service d'oncologie medicale

    Angers, France

  • ICO - Site René Gauducheau - Service d'Oncologie medicale

    Saint-Herblain, France

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

    Padova, Italy

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

    Forlì, Italy

  • IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica

    San Giovanni Rotondo, Italy

  • Institut Bergonié - Service d'Oncologie Médicale

    Bordeaux, France

  • Institut Jules Bordet - Medical Oncology

    Brussels, Belgium

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

    Strasbourg, France

  • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A

    Naples, Italy

  • Istituto Nazionale Tumori Regina Elena IRCCS - Urologia

    Naples, Italy

  • Johns Hopkins University

    Baltimore, Maryland, 21287-7049, United States

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Kliniken Maria Hilf GmbH - Klinik fuer Urologie

    Muenchen, North Rhine-Westphalia, 41063, Germany

  • Kliniken Maria Hilf GmbH - Klinik fuer Urologie

    Mönchengladbach, Germany

  • Liverpool Hospital - PARENT

    Liverpool, Australia

  • Macquarie University Hospital - PARENT

    Sydney, Australia

  • Multicare Health System Tacoma General Hospital

    Tacoma, Washington, 98405, United States

  • National Cancer Center

    Gyeonggi-do, South Korea

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Ospedale San Raffaele - U.O. di Oncologia Medica

    Milan, Italy

  • Ospedale Santa Maria delle Croci

    Ravenna, Italy

  • Royal Preston Hospital - Rosemere Cancer Centre

    Preston, United Kingdom

  • Samsung Medical Center

    Seoul, South Korea

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Sunshine Hospital - PARENT

    Footscray, Australia

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tasman Oncology Research Ltd - Oncology

    Southport, Australia

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

    Seoul, South Korea

  • The Christie Hospital - Dept of Oncology

    Manchester, United Kingdom

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The Kinghorn Can Cen

    Westmead, Australia

  • The Ottawa Hospital Cancer Centre

    Ottawa, Canada

  • Universitaetsklinikum Essen - Westdeutsches Tumorzentrum

    Essen, Germany

  • Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2

    Frankfurt, Germany

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

    Halle, Saxony-Anhalt, 0044384, Germany

  • Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie

    Münster, Germany

  • Universitaetsklinikum Tuebingen - Klinik fuer Urologie

    Tübingen, Germany

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

    Wuerzburg, Belgium

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

    Halle, Germany

  • Universitair Ziekenhuis Gent - Medical Oncology

    Ghent, Belgium

  • University General Hospital "Attikon"

    Athens, Greece

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

    Kansas City, Kansas, 66205, United States

  • University of Wisconsin Cancer Center

    Madison, Wisconsin, 53706, United States

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Canada

  • ZNA Middelheim - Middelheim - account 2

    Antwerp, Belgium

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Other studies related to the condition(s) this trial covers.