Status:
COMPLETED
A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
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 seek...
Eligibility Criteria
Inclusion
- 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
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
July 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT05431777
Start Date
July 19 2022
End Date
January 16 2023
Last Update
April 1 2025
Active Locations (16)
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1
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 460-0001
2
Asahi General Hospital
Asahi, Chiba, Japan, 289-2511
3
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
4
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan, 503-8502