Actively Recruiting

All Genders
ID06011954

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Led by Astellas Pharma Korea, Inc. · Updated on 2026-05-14

202

Participants Needed

18

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Astellas Pharma Korea, Inc.

Lead Sponsor

S

Seagen Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying adults in South Korea who have locally advanced or metastatic urothelial cancer, a type of cancer in the bladder lining that has spread to other parts of the body. The study focuses on people who have been prescribed PADCEV Injection (enfortumab vedotin) as part of their cancer treatment. The main goal is to collect information about treatment outcomes and any medical problems that arise during care. Participants receive PADCEV Injection in doses of 20 mg or 30 mg through intravenous administration, following the approved drug label and routine clinical practice. This is an observational study, meaning the treatment is given as part of standard care, and the researchers gather data without changing the treatment. The observation period lasts up to 48 weeks after the first dose. If treatment stops earlier, participants are followed for 30 days after the last dose or until they start a different cancer medicine. During the study, medical records will be reviewed regularly to monitor any adverse events, including serious or unexpected reactions, and to track the status of the cancer. Researchers will also check overall survival and progression-free survival up to 48 weeks. Participants' health will be observed for about one year, with data collection focusing on safety and treatment effects in real-world clinical settings.

CONDITIONS

Brief Title

A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who receive treatment with PADCEV Injection, according to the approved local label.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 48 weeks after the first administration of PADCEV

Participants who receive PADCEV injection in routine clinical practice are observed for safety and effectiveness.

Visits scheduled according to routine clinical practice up to 48 weeks

Trial Site Locations

Total: 18 locations

1

Site KR82001

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

Actively Recruiting

2

Site KR82012

Suwon, Gyeonggi-do, South Korea, 16247

Actively Recruiting

3

Site KR82008

Suwon, Gyeonggi-do, South Korea, 16500

Actively Recruiting

4

Site KR82007

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

Completed

5

Site KR82013

Jeonju, Jeonbuk-do, South Korea, 54907

Actively Recruiting

6

Site KR82015

Busan, South Korea, 47392

Active, Not Recruiting

7

Site KR82010

Busan, South Korea, 48108

Completed

8

Site KR82009

Busan, South Korea, 49201

Active, Not Recruiting

9

Site KR82016

Busan, South Korea, 50612

Completed

10

Site KR82014

Daegu, South Korea, 42415

Actively Recruiting

11

Site KR82018

Daejeon, South Korea, 35365

Actively Recruiting

12

Site KR82004

Incheon, South Korea, 21565

Active, Not Recruiting

13

Site KR82002

Seoul, South Korea, 02841

Actively Recruiting

14

Site KR82005

Seoul, South Korea, 03181

Actively Recruiting

15

Site KR82003

Seoul, South Korea, 03722

Active, Not Recruiting

16

Site KR82017

Seoul, South Korea, 06351

Active, Not Recruiting

17

Site KR82006

Seoul, South Korea, 07417

Actively Recruiting

18

Site KR82011

Seoul, South Korea, 07985

Actively Recruiting

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Research Team

A

Astellas Pharma Global Development, Inc.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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