Trial Title:
A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
NCT ID:
NCT06011954
Condition:
Urothelial Cancer
Conditions: Keywords:
Urothelial Cancer
Bladder Cancer
enfortumab vedotin
PADCEV
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Enfortumab Vedotin
Description:
Intravenous
Arm group label:
PADCEV
Other name:
PADCEV
Other name:
ASG-22CE
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.
Criteria for eligibility:
Study pop:
- 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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site KR82001
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82002
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82003
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82004
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82005
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82006
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82007
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82008
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82009
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82010
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82011
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82013
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82014
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82015
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82016
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Site KR82017
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Start date:
November 1, 2023
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Astellas Pharma Korea, Inc.
Agency class:
Industry
Collaborator:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Astellas Pharma Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011954
