International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC (ARON-2PLUS)

February 12, 2026 updated by: Aron Research Foundation Ets

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

361

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients affected by locally advanced or metastatic urothelial cancer, or with rare genitourinary tumors, treated with enfortumab vedotin plus pembrolizumab

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival in patients with la/mUC or rare GU tumors
Time Frame: December 2030
time from the start of the therapy until death from any cause
December 2030
progression-free survival
Time Frame: December 2030
time from the start of the therapy until progression or death from any cause.
December 2030

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of adverse event
Time Frame: December 2030
Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
December 2030
Objective Response Rate (ORR) Based on RECIST v1.1
Time Frame: December 2030
The Objective Response Rate (ORR) is defined as the proportion of patients achieving either a Complete Response (CR) or a Partial Response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
December 2030

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Clinical and Pathological Covariates on Overall Survival (OS) as Measured by the Kaplan-Meier Method.
Time Frame: December 2030
Evaluation of the prognostic significance of baseline characteristics-including smoking status (current/former vs. never), obesity (BMI ≥ 30 kg/m2), age, renal function (eGFR), primary tumor location (upper vs. lower tract), and concomitant medication use on Overall Survival. OS is defined as the time from the first dose of EV+P to death from any cause. OS will be estimated by the Kaplan-Meier method with Rothman's 95% Confidence Intervals (CI) and compared between subgroups using the log-rank test. To identify independent prognostic factors, univariable and multivariable analyses will be performed using Cox proportional hazards models, reporting Hazard Ratios (HR) and their corresponding 95% CIs.
December 2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aron Research Foundation Ets

Investigators

  • Principal Investigator: Matteo Santoni, Aron Research Foundation Ets

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARON-2PLUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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