A Study to Learn About First-line Avelumab Maintenance in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Brief Title

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

Official Title

Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Patterns and Outcomes in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With First-line Avelumab Maintenance

Brief Summary

      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.

Study Type

Observational

Primary Outcome

Description of patient characteristics at baseline

Secondary Outcome

 Time to Failure (TTF)

Condition

Urothelial Carcinoma

Intervention

Avelumab

Study Arms / Comparison Groups

 Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Description:  Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

July 19, 2022

Completion Date

January 16, 2023

Primary Completion Date

January 16, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L
             maintenance therapy.

          2. Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021
             (regulatory approval date) to 30 Nov 2021.

          3. 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.

Gender

All

Ages

0 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, ,

Location Countries

Japan

Location Countries

Japan

Administrative Informations

NCT ID

NCT05431777

Organization ID

B9991048

Responsible Party

Sponsor

Study Sponsor

Pfizer

Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer

Verification Date

March 2023