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Personalized vaccine + immunotherapy aims to stop bladder cancer return

NCT ID NCT06534983

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 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 must have the capacity to participate/enroll in the study and to provide informed consent * Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or upper urinary tract * Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control \[UICC\]/American Joint Committee on Cancer \[AJCC\] 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0 * Surgical resection of MIUC of the bladder or upper tract * Participants who have received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible * Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant refusal, cisplatin ineligibility or investigator decision * Tumor tissue must be provided for biomarker analysis * Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization * Full recovery from cystectomy or nephroureterectomy within 120 days following surgery * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Negative human immunodeficiency virus (HIV) test at screening * Negative hepatitis B surface antigen (HbsAg) test at screening * Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< 500 international units/milliliter (IU/mL) * Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening Exclusion Criteria: * Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor * Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment * Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection * Prior active malignancies within 3 years prior to randomization * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment

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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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