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NCT Number: NCT07420855

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Macerata

Province of Macerata, 62100, Italy

Location contact

Matteo Santoni

CONTACT

[email protected]

+39

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. progression-free survival

    Time frame: December 2030

    time from the start of the therapy until progression or death from any cause.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Santoni, Medical Doctor

CONTACT

[email protected]

+39

Sponsors and collaborators

Lead sponsor

Aron Research Foundation Ets

Other

Registry information

Official study 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)

Acronym: ARON-2PLUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2030
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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