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

Study Overview
=================
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: Have UC that cannot be operated on or has spread to other parts of the body Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy 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: To describe the clinical and demographic characteristics of the study population To estimate real-world progression-free survival (rwPFS) To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy To describe treatment patterns after initiation of avelumab as 1L maintenance therapy To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy

Official Title
-----------------
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

Conditions
-----------------
Urothelial Cancer

Intervention / Treatment
-----------------
* Drug: Avelumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients with locally advanced or metastatic urothelial cancer<br> | Drug: Avelumab<br>* As provided in real world practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real world overall survival | Time between avelumab initiation until date of death from any cause or end of follow-up | September 2020 to April 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real world progression free survival | Time between avelumab initiation until earliest of: Date of first progression Date of death from any cause | September 2020 to April 2024 | 
| Adverse events explicitly attributed to avelumab | 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 | September 2020 to April 2024 | 
| All-cause healthcare resource burden | Mean and median number, per patient, of the following: Accident and emergency visits Hospitalisations Duration of hospitalisation (days) | September 2020 to April 2024 |