NCT05366725

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	As provided in real world practice

Timeline

• Start date: 2022-06-29
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2022-05-09
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

10 sites across 1 country: United Kingdom