A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy
NCT ID: NCT05366725
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
106 participants
OBSERVATIONAL
2022-06-29
2024-06-27
Brief Summary
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This study is seeking participants who:
1. Have UC that cannot be operated on or has spread to other parts of the body
2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
4. Are 18 years or older on the date that they start taking Avelumab
All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.
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Detailed Description
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The secondary objectives are:
1. To describe the clinical and demographic characteristics of the study population
2. To estimate real-world progression-free survival (rwPFS)
3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy
4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy
5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population
6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Adult patients with locally advanced or metastatic urothelial cancer
Avelumab
As provided in real world practice
Interventions
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Avelumab
As provided in real world practice
Eligibility Criteria
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Inclusion Criteria
2. Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
3. 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
4. Patients aged ≥18 years on the date that they commenced avelumab -
Exclusion Criteria
2. Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab
18 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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University Hospitals Bristol
Bristol, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
University College London Hospital
London, , United Kingdom
Guy's and St Thomas' Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Clatterbridge Hospital
Metropolitan Borough of Wirral, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
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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B9991047
Identifier Type: -
Identifier Source: org_study_id
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