A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread
NCT ID: NCT05431777
Last Updated: 2025-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
79 participants
OBSERVATIONAL
2022-07-19
2023-01-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy
Avelumab
As provided in real world setting
Interventions
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Avelumab
As provided in real world setting
Eligibility Criteria
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Inclusion Criteria
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.
0 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
St. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
SHOWA University Fujigaoka Hospital
Yokohama, Kanagawa, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Akita University Hospital
Akita, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
University Hospital Kyoto Prefectural University of Medicine IEC
Kyoto, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Toyama University Hospital
Toyama, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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B9991048
Identifier Type: -
Identifier Source: org_study_id
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