International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Urothelial Cancer, Urothelial Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Primary outcome measures
- overall survival in patients with la/mUC or rare GU tumors [Time frame: December 2030]
- progression-free survival [Time frame: December 2030]
Secondary outcome measures (2)
- Evaluation of adverse event [Time frame: December 2030]
- Objective Response Rate (ORR) Based on RECIST v1.1 [Time frame: December 2030]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Ospedale di Macerata — Province of Macerata
Identifiers
NCT: NCT07420855 · ARON-2PLUS