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

Astellas

Status: Enrolling

Conditions: Urothelial Cancer

Treatments: Drug: Enfortumab Vedotin

Study type: Observational

Funder types: Industry

Identifiers

NCT06011954

7465-PV-0001

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

202 participants in 1 patient group

PADCEV

Description:

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.

Treatment:

Drug: Enfortumab Vedotin