NCT06011954

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Nov 2023Jul 2027

First Submitted

Initial submission to the registry

August 22, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

August 22, 2023

Last Update Submit

April 13, 2026

Conditions

Urothelial Cancer

Keywords

Urothelial CancerBladder Cancerenfortumab vedotinPADCEV

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (2)

  • Overall survival

    Up to 48 weeks after the first administration of PADCEV

  • Progression free survival

    Up to 48 weeks after the first administration of PADCEV

Study Arms (1)

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

Interventions

Enfortumab VedotinDRUG

Intravenous

Also known as: PADCEV, ASG-22CE
PADCEV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who receive treatment with PADCEV Injection, according to the approved local label.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Site KR82001

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

Site KR82012

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Site KR82008

Suwon, Gyeonggi-do, 16500, South Korea

RECRUITING

Site KR82007

Jeollanam-do, Jeollanam-do, 58128, South Korea

COMPLETED

Site KR82013

Jeonju, Jeonbuk-do, 54907, South Korea

RECRUITING

Site KR82015

Busan, 47392, South Korea

ACTIVE NOT RECRUITING

Site KR82010

Busan, 48108, South Korea

RECRUITING

Site KR82009

Busan, 49201, South Korea

ACTIVE NOT RECRUITING

Site KR82016

Busan, 50612, South Korea

RECRUITING

Site KR82014

Daegu, 42415, South Korea

RECRUITING

Site KR82018

Daejeon, 35365, South Korea

RECRUITING

Site KR82004

Incheon, 21565, South Korea

ACTIVE NOT RECRUITING

Site KR82002

Seoul, 02841, South Korea

RECRUITING

Site KR82005

Seoul, 03181, South Korea

RECRUITING

Site KR82003

Seoul, 03722, South Korea

ACTIVE NOT RECRUITING

Site KR82017

Seoul, 06351, South Korea

RECRUITING

Site KR82006

Seoul, 07417, South Korea

RECRUITING

Site KR82011

Seoul, 07985, South Korea

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

enfortumab vedotin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Central Contact

    Astellas Pharma Korea, Inc.

    STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc.

CONTACT

800-888-7704astellas.registration@astellas.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 25, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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/.

Locations

KR(18)