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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07339878

Acronym

FLORAL

Enrollment

Registered

2026-01-14

Start date

2025-04-20

Completion date

2026-04-20

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Urothelial Carcinoma

Keywords

Urothelial Carcinoma, Enfortumab Vedotin, Pembrolizumab

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients over 18 years of age * Metastatic urothelial carcinoma * Treated with first-line metastatic therapy since October 2024

Exclusion criteria

* Patient who expressed opposition to participating in the study

Design outcomes

Primary

Measure	Time frame
Description of the clinical characteristics of patients recently treated with first-line metastatic therapy for urothelial carcinoma	Up to 12 months

Countries

France

Contacts

Primary ContactPhilippe Barthélémy, MD

philippe.barthelemy@chru-strasbourg.fr33 3 88 12 76 70

Outcome results