Actively Recruiting
Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma: Observational, Multicenter, Real-world Study
Led by University Hospital, Strasbourg, France · Updated on 2026-01-14
50
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with metastatic urothelial carcinoma to understand the characteristics and treatment choices for first-line metastatic therapy in real-world settings. This observational, multicenter study aims to identify why clinicians choose platinum-based chemotherapy over the newer combination of Enfortumab Vedotin and Pembrolizumab for some patients. The study builds on recent findings from the EV-302 trial and focuses on treatment decisions made since late 2024. Participants included in this study are those who have received first-line metastatic treatment since October 2024. The study does not involve administering treatments but observes and records the therapies patients have received in routine clinical practice. The main treatment options under observation are the combination of Enfortumab Vedotin and Pembrolizumab versus platinum-based chemotherapy with or without avelumab. During the study, researchers will collect data on patient clinical characteristics and treatment details for up to 12 months. The primary outcome is to describe these characteristics and understand treatment choices. Since this is an observational study, participants will not undergo additional interventions but will be monitored through data collection. The study is sponsored by the University Hospital in Strasbourg, France, and will run until April 2026.
CONDITIONS
Brief Title
Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Diagnosed with metastatic urothelial carcinoma
- Treated with first-line metastatic therapy since October 2024
You will not qualify if you...
- Patient who expressed opposition to participating in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants who undergo routine care for metastatic urothelial carcinoma are observed to describe clinical characteristics during first-line metastatic treatment.
Visits according to routine clinical care
Trial Site Locations
Total: 1 location
1
Service Oncologie Médicale - CHU de Strasbourg - France
Strasbourg, France, 67091
Actively Recruiting
Research Team
P
Philippe Barthélémy, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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