A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Conditions

Urothelial Cancer

Being tested

Enfortumab Vedotin

Keywords

Urothelial Cancer, Bladder Cancer, enfortumab vedotin, PADCEV

Medical subject headings

Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Enfortumab VedotinDrug

  Also called PADCEV, ASG-22CE

  Intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: Up to 48 weeks after the first administration of PADCEV

2. 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.

   Measured: Up to 48 weeks after the first administration of PADCEV

3. 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.

   Measured: Up to 48 weeks after the first administration of PADCEV

4. 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.

   Measured: Up to 48 weeks after the first administration of PADCEV

5. 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.

   Measured: Up to 48 weeks after the first administration of PADCEV

6. Number of patients with an unexpected ADR (UADR)

   An UADR is defined as an unexpected adverse drug reaction.

   Measured: Up to 48 weeks after the first administration of PADCEV

7. Number of patients who died during the study

   The number of patients who died during the study will be recorded.

   Measured: Up to 48 weeks after the first administration of PADCEV

8. Number of patients with an AE leading to death

   The number of patients who experience an AE that leads to death will be recoded.

   Measured: Up to 48 weeks after the first administration of PADCEV

9. 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.

   Measured: Up to 48 weeks after the first administration of PADCEV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Aug 2023
2. Study start1 Nov 2023
3. Primary completion31 Jul 2027 (estimated)
4. Study completion31 Jul 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Urothelial CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.