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NCT05366725Completed

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

A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

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 worsened after receiving chemotherapy. 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.

Status (registry)
Completed
Study type
Observational
Enrollment
106 (actual)
First submitted
4 May 2022
Start date
29 Jun 2022
Primary completion date
27 Jun 2024
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
NCT number
NCT05366725

What you commit to

  • Study type: Observational
  • Participants enrolled: 106
  • From 29 Jun 2022 to the primary completion date, 27 Jun 2024
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab

Other

  • Patients whose hospital records are not available for review

Who the study is looking for

  • 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 -

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospitals Bristol
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BristolUnited KingdomUnknown status
Beatson West of Scotland Cancer Centre
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GlasgowUnited KingdomUnknown status
Royal Surrey County Hospital
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GuildfordUnited KingdomUnknown status
Guy's and St Thomas' Hospital
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LondonUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Clatterbridge Hospital
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Metropolitan Borough of WirralUnited KingdomUnknown status
Churchill Hospital
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OxfordUnited KingdomUnknown status
Royal Preston Hospital
Coordinator of this site? Confirm its status
PrestonUnited KingdomUnknown status
Lister Hospital
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StevenageUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.