Actively Recruiting
International Retrospective Study on Pembrolizumab and Enfortumab Vedotin in Adults with Metastatic Urothelial Carcinoma
Led by Matteo Santoni · Updated on 2025-04-02
367
Participants Needed
1
Research Sites
195 weeks
Total Duration
AI-Summary
What this Trial Is About
This observational study focuses on patients with metastatic Urothelial Carcinoma UC who have been treated with specific therapies. It aims to retrospectively analyze patients who received pembrolizumab as first-line therapy if they were not suitable for platinum chemotherapy, or as second-line therapy after progression following platinum-based chemotherapy. The study also includes patients treated with enfortumab vedotin after progression following platinum chemotherapy and anti-PD-1PD-L1 inhibitors. These analyses help understand treatment outcomes in this patient group. The study examines patients who received at least one cycle of pembrolizumab between January 1, 2018, and November 30, 2021, or at least one cycle of enfortumab vedotin between June 1, 2022, and July 31, 2023. Both treatments are evaluated based on their prior use following platinum-based chemotherapy and progression status. The study does not involve new treatments but reviews patient records to assess outcomes related to these therapies. Participants clinical data will be reviewed to measure overall survival, progression-free survival, and overall response rate to pembrolizumab or enfortumab vedotin. Secondary analysis includes the impact of smoking habits, obesity, and other medications on treatment outcomes. The study involves no active intervention and lasts until September 30, 2027, with data collected retrospectively to better understand treatment effectiveness and patient prognostic factors.
CONDITIONS
Brief Title
ARON-2 Study-Multicentric International Retrospective Study
Research Team
M
Matteo Santoni, MD, PhD
G
Giulia Sorgentoni
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