A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
ConditionUrothelial Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstellas Pharma Korea, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients who receive treatment with PADCEV Injection, according to the approved local label.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Enfortumab Vedotin
DrugIntravenous
Treatment groups
202 Participants
are divided into 1 treatment groupGroup A: PADCEV1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 48 weeks after the first administration of PADCEV2
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.
Time frame
Up to 48 weeks after the first administration of PADCEV3
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.
Time frame
Up to 48 weeks after the first administration of PADCEV4
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.
Time frame
Up to 48 weeks after the first administration of PADCEVSecondary outcomes
1
Overall survival
Overall survival (OS) is defined as time from start of PADCEV to death.
Time frame
Up to 48 weeks after the first administration of PADCEV2
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.
Time frame
Up to 48 weeks after the first administration of PADCEVSponsors and contacts
Click on the lead sponsor to view all of their trials.
Astellas Pharma Korea, Inc.
Lead sponsor
Seagen Inc.
Collaborator
Source ClinicalTrials.gov