A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread

Merck KGaA (EMD Serono)

Status

Completed

Conditions

Urothelial Carcinoma

Treatments

Drug: Avelumab

Study type

Observational

Funder types

Industry

Identifiers

NCT05431777

B9991048

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the current treatment patterns, safety, and effects of the study medicine (Avelumab) for the treatment of urothelial carcinoma.

This study is seeking Japanese participants who:

have urothelial cancer that has spread
are treated with Avelumab for maintenance

We will study the experiences of people receiving avelumab. This helps us learn the current treatment patterns, safety, and effects of avelumab. Participants will take part in this study up to 10 months. During this time, they will have no study visits.

Enrollment

79 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy.
Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov 2021.
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

(1) Written consent is not required for patients who were transferred to a hospital, and registration with verbal consent is acceptable.

(2) Opt-out enrollment is allowed for patients who have already died. 4)Deceased patients are also required to meet the inclusion criteria 1)-2).

Exclusion criteria

There are no exclusion criteria for this study.