Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06011954

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urothelial Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Site KR82001, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enfortumab vedotin

Drug

Intravenous

Other names: PADCEV, ASG-22CE

Primary outcomes

  1. Number of patients with an Adverse Event

    Time frame: Up to 48 weeks after the first administration of PADCEV

    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.

  2. Number of patients with an adverse drug reaction (ADR)

    Time frame: Up to 48 weeks after the first administration of PADCEV

    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.

  3. Number of patients with a serious AE (SAE)

    Time frame: Up to 48 weeks after the first administration of PADCEV

    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.

  4. Number of patients with a serious ADR (SADR)

    Time frame: Up to 48 weeks after the first administration of PADCEV

    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.

  5. Number of patients with an unexpected AE (UAE)

    Time frame: Up to 48 weeks after the first administration of PADCEV

    An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.

  6. Number of patients with an unexpected ADR (UADR)

    Time frame: Up to 48 weeks after the first administration of PADCEV

    An UADR is defined as an unexpected adverse drug reaction.

  7. Number of patients with an important risk

    Time frame: Up to 48 weeks after the first administration of PADCEV

    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.

Secondary outcomes

  1. Overall survival

    Time frame: Up to 48 weeks after the first administration of PADCEV

    Overall survival (OS) is defined as time from start of PADCEV to death.

  2. Progression free survival

    Time frame: Up to 48 weeks after the first administration of PADCEV

    Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Astellas Pharma Global Development, Inc.

CONTACT

[email protected]

800-888-7704

Sponsors and collaborators

Lead sponsor

Astellas Pharma Korea, Inc.

Industry

Collaborators

  • Seagen Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.