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Personalized vaccine + immunotherapy aims to stop bladder cancer return

NCT ID NCT06534983

Ongoing Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 7 times

Summary

This phase 2 trial tests whether adding a personalized cancer vaccine (autogene cevumeran) to the immunotherapy drug nivolumab can prevent high-risk bladder cancer from coming back after surgery. About 62 participants will receive either the combination or nivolumab alone. The study has been refocused on safety and treatment continuity.

What this could mean

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

Active substance
autogene cevumeran (personalized cancer vaccine) plus nivolumab (immunotherapy)
What this could lead to
If it works, this combination could help prevent high-risk bladder cancer from coming back after surgery.
What could go wrong
This is a small, early-phase trial that has been scaled back to focus on safety. The vaccine is personalized, which adds complexity, and it's unclear if the combination is better than nivolumab alone.

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

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma infiltrating urothelial carcinoma

As listed by the trial registrant

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

MUSCLE-INVASIVE UROTHELIAL CARCINOMA

Contacts and locations

Locations

  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari

    Bari, Apulia, 70124, Italy

  • A.O. Universitaria S. Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • A.O.U di Verona Policlinico G.B. Rossi

    Verona, Veneto, 37134, Italy

  • AIDPORT Sp. z o. o.

    Skórzewo, 60-185, Poland

  • Aalborg Universitetshospital

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Akershus universitetssykehus

    Lørenskog, 1474, Norway

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Attikon University General Hospital

    Athens, 124 61, Greece

  • Barts & London School of Med;Medical Oncology

    London, EC1M 6BQ, United Kingdom

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796, Poland

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohisung, DUMMY_VALUE, Taiwan

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Italiano

    Ciudad Autonoma Buenos Aires, C1199ABB, Argentina

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IFO - Istituto Regina Elena

    Rome, Lazio, 00144, Italy

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174, Germany

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112, Australia

  • MSK Bergen

    Montvale, New Jersey, 07645, United States

  • MSK Commack

    Commack, New York, 11725, United States

  • MSK Monmouth

    Middletown, New Jersey, 07748, United States

  • MSK Nassau

    Uniondale, New York, 11553, United States

  • MSK Westchester

    Harrison, New York, 10604, United States

  • Marien Hospital Herne

    Herne, 44625, Germany

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228, Poland

  • Theageneio Hospital

    Thessaloniki, 546 39, Greece

  • Uniklinikum Heidelberg

    Heidelberg, 69120, Germany

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Sant Andreu de la Barca, Barcelona, 08740, Spain

  • Vivantes Klinikum Am Urban

    Berlin, 10967, Germany

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