Status:

COMPLETED

A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

Lead Sponsor:

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions:

Urothelial Cancer

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsen...

Detailed Description

The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of a...

Eligibility Criteria

Inclusion

  • Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed
  • Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
  • Patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy
  • Patients aged ≥18 years on the date that they commenced avelumab -

Exclusion

  • Patients whose hospital records are not available for review
  • Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab

Key Trial Info

Start Date :

June 29 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 27 2024

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT05366725

Start Date

June 29 2022

End Date

June 27 2024

Last Update

December 2 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

University Hospitals Bristol

Bristol, United Kingdom, BS1 3NU

2

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

3

Royal Surrey County Hospital

Guildford, United Kingdom, GU2 7XX

4

University College London Hospital

London, United Kingdom, NW1 2PG