NCT07339878

Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma

Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma: Observational, Multicenter, Real-world Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The standard first-line treatment for metastatic urothelial carcinoma has become the combination of Enfortumab Vedotin and Pembrolizumab following the publication of the EV-302 study results at the end of 2024. Another standard remains in 2025 for patients who are not eligible for the EV Pembrolizumab combination, namely platinum-based chemotherapy +/- avelumab in cases of non-progression. The objective of the FLORAL study is to determine the characteristics of these patients and the reasons that led clinicians to prefer a first-line treatment based on platinum salts.

Conditions

• Metastatic Urothelial Carcinoma

Timeline

• Start date: 2025-04-20
• Primary completion: 2026-04-01
• Completion: 2026-04-20
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: France