A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
NCT ID: NCT06011954
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
202 participants
OBSERVATIONAL
2023-11-01
2027-07-31
Brief Summary
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People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only.
This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study.
Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PADCEV
Patients who receive PADCEV Injection 20 mg and 30 mg (enfortumab vedotin) in routine clinical practice according to the drug label approved at the time of marketing authorization.
Enfortumab Vedotin
Intravenous
Interventions
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Enfortumab Vedotin
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who receive or are going to receive any investigational medicine during the observation period.
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Astellas Pharma Korea, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Korea, Inc.
Locations
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Site KR82015
Busan, Busan, South Korea
Site KR82010
Busan, Busan, South Korea
Site KR82009
Busan, Busan, South Korea
Site KR82016
Busan, Busan, South Korea
Site KR82014
Daegu, Daegu, South Korea
Site KR82001
Goyang-si, Gyeonggi-do, South Korea
Site KR82012
Suwon, Gyeonggi-do, South Korea
Site KR82008
Suwon, Gyeonggi-do, South Korea
Site KR82004
Incheon, Incheon, South Korea
Site KR82007
Jeollanam-do, Jeollanam-do, South Korea
Site KR82013
Jeonju, Jeonbuk-do, South Korea
Site KR82002
Seoul, Seoul, South Korea
Site KR82005
Seoul, Seoul, South Korea
Site KR82003
Seoul, Seoul, South Korea
Site KR82017
Seoul, Seoul, South Korea
Site KR82006
Seoul, Seoul, South Korea
Site KR82011
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Other Identifiers
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7465-PV-0001
Identifier Type: -
Identifier Source: org_study_id