Survey of Adults in South Korea with Urothelial Cancer Receiving PADCEV Injection
Official title: Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea
Run by Astellas Pharma Inc · NCT06011954 · Data updated 2026-11-12
This study looks at how well PADCEV Injection works and its side effects in adults with advanced urothelial cancer in South Korea over 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 228 (estimated) |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Drugs / interventions | Enfortumab |
| Locations | 22 sites (Goyang-si, Gyeonggi-do and 21 other locations) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT06011954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults in South Korea with locally advanced or metastatic urothelial cancer who are prescribed PADCEV Injection.
✕Probably not a fit
Patients who have contraindications for PADCEV Injection or are receiving investigational medicines during the observation period may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on adults in South Korea diagnosed with locally advanced or metastatic urothelial cancer who are receiving PADCEV Injection as part of their standard treatment. The study aims to collect data on treatment outcomes and any medical issues that arise during the observation period, which lasts up to 48 weeks after the first dose of PADCEV. Participants will be monitored through their medical records to assess the effectiveness and safety of the treatment in a real-world setting.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of PADCEV Injection for patients with urothelial cancer.
How similar studies have gone: While this study is observational and focuses on a specific treatment, similar studies have shown success in evaluating treatment outcomes for cancer therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Site KR82001
Goyang-si, Gyeonggi-do, South Korea Recruiting -
Site KR82012
Suwon, Gyeonggi-do, South Korea Recruiting -
Site KR82008
Suwon, Gyeonggi-do, South Korea Recruiting -
Site KR82007
Jeollanam-do, Jeollanam-do, South Korea Recruiting -
Site KR82013
Jeonju, Jeonbuk-do, South Korea Recruiting -
Site KR82010
Busan, South Korea Recruiting
Show 16 more locations
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Site KR82010
Busan, South Korea Recruiting -
Site KR82014
Daegu, South Korea Recruiting -
Site KR82018
Daejeon, South Korea Recruiting -
Site KR82001
Goyang-si, South Korea Recruiting -
Site KR82004
Incheon, South Korea Recruiting -
Site KR82004
Incheon, South Korea Recruiting -
Site KR82007
Jeollanam-do, South Korea Recruiting -
Site KR82002
Seoul, South Korea Recruiting -
Site KR82005
Seoul, South Korea Recruiting -
Site KR82003
Seoul, South Korea Recruiting -
Site KR82006
Seoul, South Korea Recruiting -
Site KR82011
Seoul, South Korea Recruiting -
Site KR82015
Busan, South Korea Completed -
Site KR82009
Busan, South Korea Completed -
Site KR82016
Busan, South Korea Completed -
Site KR82017
Seoul, South Korea Active not recruiting
Study contacts
- Study coordinator: Astellas Pharma Global Development, Inc.
- Email: astellas.registration@astellas.com
- Phone: 800-888-7704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.