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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urothelial Cancer
• Intervention / Treatment: Drug: Enfortumab Vedotin

• Study Type: Observational
• Enrollment (Estimated): 202

Contacts and Locations

• Study Contact: Name: Astellas Pharma Global Development, Inc.; Phone Number: 800-888-7704; Email: Astellas.registration@astellas.com

Study Locations

• South Korea
  • Busan, South Korea, 47392
    • Active, not recruiting
    • Site KR82015
  • Busan, South Korea, 49201
    • Active, not recruiting
    • Site KR82009
  • Busan, South Korea, 48108
    • Completed
    • Site KR82010
  • Busan, South Korea, 50612
    • Completed
    • Site KR82016
  • Daegu, South Korea, 42415
    • Recruiting
    • Site KR82014
  • Daejeon, South Korea, 35365
    • Recruiting
    • Site KR82018
  • Incheon, South Korea, 21565
    • Active, not recruiting
    • Site KR82004
  • Seoul, South Korea, 02841
    • Recruiting
    • Site KR82002
  • Seoul, South Korea, 03181
    • Recruiting
    • Site KR82005
  • Seoul, South Korea, 07417
    • Recruiting
    • Site KR82006
  • Seoul, South Korea, 07985
    • Recruiting
    • Site KR82011
  • Seoul, South Korea, 03722
    • Active, not recruiting
    • Site KR82003
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Site KR82017
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10408
      • Recruiting
      • Site KR82001
    • Suwon, Gyeonggi-do, South Korea, 16247
      • Recruiting
      • Site KR82012
    • Suwon, Gyeonggi-do, South Korea, 16500
      • Recruiting
      • Site KR82008
  • Jeollanam-do
    • Jeollanam-do, Jeollanam-do, South Korea, 58128
      • Completed
      • Site KR82007
  • Jeonbuk-do
    • Jeonju, Jeonbuk-do, South Korea, 54907
      • Recruiting
      • Site KR82013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Adult participants with locally advanced (LA) or metastatic urothelial cancer (mUC) in South Korea who are prescribed PADCEV Injection and have previously received a Programmed death receptor-1 or Programmed death-ligand 1 inhibitor and have received a platinum containing chemotherapy.
• Adult participants with LA or mUC in South Korea who are prescribed PADCEV Injection in combination with pembrolizumab.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Enfortumab Vedotin; Intravenous; Other Names: ASG-22CE; PADCEV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with an Adverse Event	Adverse events (AEs) will be summarized using MedDRA. An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	Up to 48 weeks after the first administration of PADCEV
Number of patients with an adverse drug reaction (ADR)	An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.	Up to 48 weeks after the first administration of PADCEV
Number of patients with a serious AE (SAE)	An AE is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.	Up to 48 weeks after the first administration of PADCEV
Number of patients with a serious ADR (SADR)	An ADR is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.	Up to 48 weeks after the first administration of PADCEV
Number of patients with an unexpected AE (UAE)	An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.	Up to 48 weeks after the first administration of PADCEV
Number of patients with an unexpected ADR (UADR)	An UADR is defined as an unexpected adverse drug reaction.	Up to 48 weeks after the first administration of PADCEV
Number of patients with an important risk	An important risk is classified as an important identified risk and an important potential risk. An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug."Important Identified Risks" are identified risks that have the potential to affect the risk-benefit balance of a product. An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug."Important Potential Risks" are potential risks that have the potential to affect the risk-benefit balance of a product.	Up to 48 weeks after the first administration of PADCEV

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival (OS) is defined as time from start of PADCEV to death.	Up to 48 weeks after the first administration of PADCEV
Progression free survival	Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first.	Up to 48 weeks after the first administration of PADCEV

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.
• Collaborators: Seagen Inc.
• Investigators: Study Director: Central Contact, Astellas Pharma Korea, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bladder Cancer; Urothelial Cancer; PADCEV; enfortumab vedotin
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; enfortumab vedotin
• Other Study ID Numbers: 7465-PV-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.