Clinical trial NCT06011954: A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
Official title: Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Cancer
Keywords: Urothelial Cancer
Bladder Cancer
enfortumab vedotin
PADCEV
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Seagen Inc.
First posted: 2023-08-25
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients with an Adverse Event
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Number of patients with an adverse drug reaction (ADR)
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Number of patients with a serious AE (SAE)
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Number of patients with a serious ADR (SADR)
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Number of patients with an unexpected AE (UAE)
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Number of patients with an unexpected ADR (UADR)
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Number of patients with an important risk
timeFrame: Up to 48 weeks after the first administration of PADCEV
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 48 weeks after the first administration of PADCEV
measure: Progression free survival
timeFrame: Up to 48 weeks after the first administration of PADCEV
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Site KR82001
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Site KR82012
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Site KR82008
state: Gyeonggi-do
city: Jeonju-si
country: Korea, Republic of
facility: Site KR82013
state: Jeonbuk-do
city: Busan
country: Korea, Republic of
facility: Site KR82015
city: Busan
country: Korea, Republic of
facility: Site KR82010
city: Busan
country: Korea, Republic of
facility: Site KR82009
city: Busan
country: Korea, Republic of
facility: Site KR82016
city: Daegu
country: Korea, Republic of
facility: Site KR82014
city: Incheon
country: Korea, Republic of
facility: Site KR82004
city: Jeollanam-do
country: Korea, Republic of
facility: Site KR82007
city: Seoul
country: Korea, Republic of
facility: Site KR82002
city: Seoul
country: Korea, Republic of
facility: Site KR82005
city: Seoul
country: Korea, Republic of
facility: Site KR82003
city: Seoul
country: Korea, Republic of
facility: Site KR82017
city: Seoul
country: Korea, Republic of
facility: Site KR82006
city: Seoul
country: Korea, Republic of
facility: Site KR82011
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References: