Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients who receive treatment with PADCEV Injection, according to the approved local label.
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here