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Recruiting NCT06011954

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

— Observational Urothelial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enfortumab Vedotin.
Who it may be relevant to
Registry conditions: Urothelial Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer. 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.

Interventions

  • Drug Enfortumab Vedotin
    Intravenous

Primary outcome measures

  • Number of patients with an Adverse Event [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Number of patients with an adverse drug reaction (ADR) [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Number of patients with a serious AE (SAE) [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Number of patients with a serious ADR (SADR) [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Number of patients with an unexpected AE (UAE) [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Number of patients with an unexpected ADR (UADR) [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Number of patients with an important risk [Time frame: Up to 48 weeks after the first administration of PADCEV]
Secondary outcome measures (2)
  • Overall survival [Time frame: Up to 48 weeks after the first administration of PADCEV]
  • Progression free survival [Time frame: Up to 48 weeks after the first administration of PADCEV]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 18 centers
  • Site KR82001 — Goyang-si
  • Site KR82012 — Suwon
  • Site KR82008 — Suwon
  • Site KR82007 — Jeollanam-do
  • Site KR82013 — Jeonju
  • Site KR82015 — Busan
  • Site KR82010 — Busan
  • Site KR82009 — Busan
  • … and 10 more centers

Identifiers

NCT: NCT06011954 · 7465-PV-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗