An observational study in Urothelial Cancer, sponsored by Astellas Pharma Korea, Inc.. Recruiting at 22 sites in South Korea. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Astellas Pharma Korea, Inc. (part of Astellas Pharma Inc) · Observational
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 228 is above the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Astellas Pharma Korea, Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Intravenous
Also known as: PADCEV, ASG-22CE
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 48 weeks after the first administration of PADCEV
Number of patients who died during the study
The number of patients who died during the study will be recorded.
Time frame: Up to 48 weeks after the first administration of PADCEV
Number of patients with an AE leading to death
The number of patients who experience an AE that leads to death will be recoded.
Time frame: 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.
Time frame: Up to 48 weeks after the first administration of PADCEV
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 PADCEV
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 PADCEV
Pathological complete response (pCR)
pCR is defined as the absence of residual visual tumor in cystectomy specimen and assessed regional lympth nodes. The percentage of participants who experience pRC will be recorded.
Time frame: Up to 48 weeks after the first administration of PADCEV
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No — 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/.
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Jul 2027, 44 months after the start.
Of 202 observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 32. This study's planned 44 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.