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New study tracks nerve side effects of bladder cancer combo therapy

NCT ID NCT06657157

Knowledge-focused Sponsor: Comprehensive Cancer Center Munich (CCCM) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at nerve damage (peripheral neuropathy) in people with advanced bladder cancer who are getting a combination of two drugs, pembrolizumab and enfortumab vedotin, as their first treatment. About 80 participants will be followed for a year to see how often nerve problems occur, how severe they are, and how they affect daily life. The goal is to better understand these side effects to improve patient care.

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.

Participants

About 80 people

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

Started

Jan 2025

Expected to finish

Feb 2027

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.

Who is studied

Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.

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: * Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF) * Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma * Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve) * Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information Exclusion Criteria: * Patients with contraindications for enfortumab vedotin and/or pembrolizumab * Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors) * Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors * Patients who received neoadjuvant or adjuvant platinum-based chemotherapy \<12 months ago

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma peripheral nervous system disorder transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Urothelial cancer

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Department of Urology, Klinikum rechts der Isar, Technical University Munich

    RECRUITING

    Munich, Bavaria, 81675, Germany

  • Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich

    RECRUITING

    Munich, Bavaria, 81377, Germany

  • Department of Urology, University Hospital of Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Department of Urology, University Hosptial Augsburg

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

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