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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07420855

Acronym

ARON-2PLUS

Enrollment

361

Registered

2026-02-19

Start date

2026-02-01

Completion date

2030-12-01

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Urothelial Cancer, Urothelial Cancer

Keywords

urothelial cancer, pembrolizumab, enfortumab vedotin, rare genitourinary tumors

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Evaluation of adverse event	December 2030	Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Objective Response Rate (ORR) Based on RECIST v1.1	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.

Countries

Italy

Contacts

CONTACTMatteo Santoni, Medical Doctor

matteo.santoni82@gmail.com+39

PRINCIPAL_INVESTIGATORMatteo Santoni

Aron Research Foundation Ets

Outcome results