Clinical trial · Observational
International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC
International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced/Metastatic Urothelial Cancer (ARON-2PLUS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The ARON-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced/metastatic Urothelial Cancer. Two supplementary optional studies are designed: one is related to CT scans evaluation for 3D reconstruction analysis; the other one is an omic analysis on FFPE tissue.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Urothelial Cancer | — | UNRESOLVED | — |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- overall survival in patients with la/mUC or rare GU tumors
- timeFrame
- December 2030
- description
- time from the start of the therapy until death from any cause
- measure
- progression-free survival
- timeFrame
- December 2030
- description
- time from the start of the therapy until progression or death from any cause.
Secondary outcomes (2)
- measure
- Evaluation of adverse event
- timeFrame
- December 2030
- description
- Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \>18years * Histologically confirmed diagnosis of la/mUC of upper and/or lower urinary tract or histologically confirmed diagnosis of rare GU tumors. * Histologically or radiologically confirmed metastatic disease * Patients treated with first-line EV+P combination Exclusion Criteria: * Patients without histologically confirmed diagnosis of UC * Patients without histologically or radiologically confirmed la or mUC
References
Publications (0)
Data not yet available