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

Completed

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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 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.

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 adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.

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

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Adult patients with locally advanced or metastatic urothelial cancer	Avelumab	-

Primary Outcome Measures

Name	Time	Method
Real world overall survival	September 2020 to June 2024	Time between avelumab initiation until date of death from any cause or end of follow-up

Secondary Outcome Measures

Name	Time	Method
Real world progression free survival	September 2020 to June 2024	Time between avelumab initiation until earliest of: * Date of first progression * Date of death from any cause
Adverse events explicitly attributed to avelumab	September 2020 to June 2024	Any AE with explicit attribution to avelumab as noted in the clinical records. Explicit attribution is not inferred by a temporal relationship between drug administration and an AE butmust be based on a definite statement of causality by a healthcare provider linking drug administration to the AE. * AE diagnosis * Outcome of AE * Classification as either serious or non-serious AE * Results in hospitalisation or prolongation of hospitalisation * Is life threatening * Resulted in death * Persistent or significant incapacity * Congenital anomaly/birth defect in any offspring * Other important medical event that may require medical or surgical intervention to avoid any of the above criteria * AEs discontinuation of avelumab * AEs leading to systemic steroid treatment
All-cause healthcare resource burden	September 2020 to June 2024	Mean and median number, per patient, of the following: * Accident and emergency visits * Hospitalisations * Duration of hospitalisation (days)

Locations (10): University Hospitals Bristol
🇬🇧
Bristol, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧
Glasgow, United Kingdom
University College London Hospital
🇬🇧
London, United Kingdom
Royal Surrey County Hospital
🇬🇧
Guildford, United Kingdom
Guy's and St Thomas' Hospital
🇬🇧
London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
Royal Preston Hospital
🇬🇧
Preston, United Kingdom
Churchill Hospital
🇬🇧
Oxford, United Kingdom
Clatterbridge Hospital
🇬🇧
Wirral, United Kingdom
Lister Hospital
🇬🇧
Stevenage, United Kingdom