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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05366725
Study type Observational
Source Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Contact
Status Active, not recruiting
Phase
Start date June 29, 2022
Completion date November 30, 2024

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