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New drug combo aims to shrink bladder tumors before surgery

NCT ID NCT06511648

Disease control Sponsor: Spanish Oncology Genito-Urinary Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial tests erdafitinib alone or with cetrelimab before surgery in 90 people with muscle-invasive bladder cancer that has specific gene changes (FGFR). Participants cannot take standard cisplatin chemotherapy. The goal is to see if the drugs can eliminate or shrink the tumor before removal, improving outcomes.

What this could mean

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

Active substance
erdafitinib and cetrelimab
What this could lead to
If successful, this could offer a new treatment option before surgery for people with a specific type of bladder cancer who cannot take standard chemotherapy.
What could go wrong
This is an early phase 2 trial with only 90 participants, so results are not yet proven. The drugs may cause side effects or not work as hoped.

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 90 people

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

Started

Mar 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study. 2. Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no later than 3 months prior to start the screening visit. 3. Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site. 4. Age ≥ 18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Decline or ineligible ("unfit") for cisplatin-based chemotherapy 7. Presence of a selected FGFR alteration on analysis of tumour biopsy 8. Adequate organ function 9. No other malignancy 10. Willingness to avoid pregnancy or fathering children Exclusion Criteria: 1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer. 2. Has tumour with any neuroendocrine or small cell component. 3. Patients who are not considered fit for cystectomy or reject cystectomy. 4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy. 5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma transitional cell carcinoma

As listed by the trial registrant

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

Muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O. Ordine Mauriziano, Ospedale Umberto I

    WITHDRAWN

    Turi, 10128, Italy

  • Barts Health NHS Trust

    RECRUITING

    London, W6 8JA, United Kingdom

  • CLCC Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • CLCC Léon Bérard

    WITHDRAWN

    Lyon, 69008, France

  • Charing Cross Hospital

    RECRUITING

    London, United Kingdom

  • Complexo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, Galicia, 15006, Spain

  • Fundación Instituto Valenciano De Oncología

    RECRUITING

    Valencia, 46009, Spain

  • Hospital Clínic De Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clínico Universitario De Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Hospital De Sabadell (Parc Taulí)

    RECRUITING

    Barcelona, Catalonia, 08208, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Galicia, 27003, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario de Toledo

    RECRUITING

    Toledo, 45007, Spain

  • ICO l' Hospitalet

    NOT_YET_RECRUITING

    Barcelona, 08908, Spain

  • IRCCS San Raffaele Hospital and Scientific Institute

    RECRUITING

    Milan, 20132, Italy

  • IUCT

    RECRUITING

    Toulouse, 31059, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Institut Mutualiste Montsouris

    RECRUITING

    Paris, 75014, France

  • Ospedale Molinette

    RECRUITING

    Turin, 10126, Italy

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, S10 2SJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    WITHDRAWN

    Lancaster, LA1 4RP, United Kingdom

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