NCT07339878

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Metastatic Urothelial Carcinoma

Keywords

Urothelial CarcinomaEnfortumab VedotinPembrolizumab

Outcome Measures

Primary Outcomes (1)

  • Description of the clinical characteristics of patients recently treated with first-line metastatic therapy for urothelial carcinoma

    Up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adut atient with metastatic urothelial carcinoma and reated with first-line metastatic therapy since October 2024

You may qualify if:

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

You may not qualify if:

  • Patient who expressed opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Oncologie Médicale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Philippe Barthélémy, MD

CONTACT

33 3 88 12 76 70philippe.barthelemy@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

April 20, 2025

Primary Completion

April 1, 2026

Study Completion

April 20, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

FR(1)