Choosing first-line treatment for metastatic urothelial carcinoma
Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma: Observational, Multicenter, Real-world Study
University Hospital, Strasbourg, France · NCT07339878
This study will look at adults with metastatic urothelial carcinoma treated since October 2024 to see which patient features and clinician reasons lead to choosing platinum-based chemotherapy instead of enfortumab vedotin plus pembrolizumab as first-line therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Drugs / interventions | Enfortumab, Pembrolizumab, avelumab, chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07339878 on ClinicalTrials.gov |
What this trial studies
This observational cohort will collect clinical and treatment data on adults with metastatic urothelial carcinoma who began first-line systemic therapy from October 2024 onward at CHU de Strasbourg. Investigators will record patient characteristics, tumor features, comorbidities, laboratory results, and documented clinician reasons for choosing platinum-based chemotherapy versus enfortumab vedotin plus pembrolizumab. No investigational interventions are given; data are obtained from medical records and clinician or patient reports with consent. Analyses will describe factors associated with selection of platinum-based therapy and the frequency of reasons cited by treating physicians.
Who should consider this trial
Good fit: Adults (≥18 years) with metastatic urothelial carcinoma who started first-line systemic therapy at or after October 2024 and receive care at CHU de Strasbourg.
Not a fit: Patients who began treatment before October 2024, who have non-urothelial cancers, or who refuse consent are not eligible and are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, the study could help doctors and patients choose the most appropriate first-line therapy by clarifying which patient features lead to selection of platinum-based chemotherapy over enfortumab vedotin plus pembrolizumab.
How similar studies have performed: Randomized trials like EV-302 established the efficacy of enfortumab vedotin plus pembrolizumab, but real-world studies specifically examining why clinicians choose platinum-based chemotherapy instead are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Service Oncologie Médicale - CHU de Strasbourg - France — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Philippe Barthélémy, MD
- Email: philippe.barthelemy@chru-strasbourg.fr
- Phone: 33 3 88 12 76 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Enfortumab Vedotin, Pembrolizumab