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South korea tracks Real-World safety of bladder cancer drug PADCEV

NCT ID NCT06011954

Knowledge-focused Sponsor: Astellas Pharma Korea, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study monitors 202 adults in South Korea with advanced bladder cancer who are receiving the drug PADCEV (enfortumab vedotin) as part of their normal care. Researchers will track side effects and how well the cancer responds for up to a year. No new treatment is given; the goal is to gather real-world safety and effectiveness data.

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 (PADCEV)
What this could lead to
If successful, this study will provide real-world safety and effectiveness data on PADCEV for advanced bladder cancer in South Korean patients.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be limited by small sample size and short follow-up.

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 202 people

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

Started

Nov 2023

Expected to finish

Jul 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.

Who is studied

* Adult participants with locally advanced (LA) or metastatic urothelial cancer (mUC) in South Korea who are prescribed PADCEV Injection and have previously received a Programmed death receptor-1 or Programmed death-ligand 1 inhibitor and have received a platinum containing chemotherapy. * Adult participants with LA or mUC in South Korea who are prescribed PADCEV Injection in combination with pembrolizumab.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 who receive treatment with PADCEV Injection, according to the approved local label. Exclusion Criteria: * Patients with any contraindication for PADCEV Injection, according to the approved local label. * Patients who receive or are going to receive any investigational medicine during the observation period.

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Conditions

The condition(s) this trial relates to.

Urinary Bladder Neoplasms 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

    10 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

  • Site KR82001

    ACTIVE_NOT_RECRUITING

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • Site KR82002

    RECRUITING

    Seoul, 02841, South Korea

  • Site KR82003

    RECRUITING

    Seoul, 03722, South Korea

  • Site KR82004

    ACTIVE_NOT_RECRUITING

    Incheon, 21565, South Korea

  • Site KR82005

    RECRUITING

    Seoul, 03181, South Korea

  • Site KR82006

    RECRUITING

    Seoul, 07417, South Korea

  • Site KR82007

    COMPLETED

    Jeollanam-do, Jeollanam-do, 58128, South Korea

  • Site KR82008

    RECRUITING

    Suwon, Gyeonggi-do, 16500, South Korea

  • Site KR82009

    COMPLETED

    Busan, 49201, South Korea

  • Site KR82010

    COMPLETED

    Busan, 48108, South Korea

  • Site KR82011

    RECRUITING

    Seoul, 07985, South Korea

  • Site KR82012

    RECRUITING

    Suwon, Gyeonggi-do, 16247, South Korea

  • Site KR82013

    RECRUITING

    Jeonju, Jeonbuk-do, 54907, South Korea

  • Site KR82014

    RECRUITING

    Daegu, 42415, South Korea

  • Site KR82015

    COMPLETED

    Busan, 47392, South Korea

  • Site KR82016

    COMPLETED

    Busan, 50612, South Korea

  • Site KR82017

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Site KR82018

    RECRUITING

    Daejeon, 35365, South Korea

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