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Bladder cancer combo shows promise in Real-World review

NCT ID NCT07420855

Knowledge-focused Sponsor: Aron Research Foundation Ets 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 back at how well a combination of two drugs—enfortumab vedotin and pembrolizumab—works as the first treatment for people with advanced bladder cancer that has spread. Researchers will collect data from 361 patients around the world to see how long they live and how the cancer responds. The goal is to learn from real-world experience, not to test a new drug.

What this could mean

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

Active substance
enfortumab vedotin plus pembrolizumab
What this could lead to
If successful, this study could confirm that this drug combination works well as a first treatment for advanced bladder cancer, potentially improving survival and guiding future standard care.
What could go wrong
This is a retrospective study, meaning it looks back at past treatments rather than testing a new approach. Results may be less reliable than a controlled trial, and the combination can cause serious side effects like immune reactions or nerve damage.

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 361 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

adult patients affected by locally advanced or metastatic urothelial cancer, or with rare genitourinary tumors, treated with enfortumab vedotin plus pembrolizumab

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: * Patients aged \>18years * Histologically confirmed diagnosis of la/mUC of upper and/or lower urinary tract or histologically confirmed diagnosis of rare GU tumors. * Histologically or radiologically confirmed metastatic disease * Patients treated with first-line EV+P combination Exclusion Criteria: * Patients without histologically confirmed diagnosis of UC * Patients without histologically or radiologically confirmed la or mUC

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Conditions

The condition(s) this trial relates to.

urothelial carcinoma

As listed by the trial registrant

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

Locally advanced or metastatic urothelial cancer 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

    1 site. 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

  • Ospedale di Macerata

    Province of Macerata, 62100, Italy

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