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ARON-2 Study-Multicentric International Retrospective Study

ARON-2 Study-Multicentric International Retrospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05290038
Enrollment
367
Registered
2022-03-22
Start date
2022-02-17
Completion date
2027-09-30
Last updated
2025-04-02

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

Conditions

Urothelial Carcinoma

Keywords

immunotherapy, real world experience, efficacy of pembrolizumab, artificial intelligence technology, Artificial Neural Network

Brief summary

The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.

Interventions

None listed

Sponsors

Matteo Santoni
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged \>18y * Histologically confirmed diagnosis of UC of upper and/or lower urinary tract * Histologically or radiologically confirmed metastatic disease * Patients treated with at least one of the following: * Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021 * Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023

Exclusion criteria

* Patients without histologically confirmed diagnosis of UC * Patients without histologically or radiologically confirmed metastatic disease

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotinNovember 15th, 2023
Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotinNovember 15th, 2023
Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotinNovember 15th, 2023

Secondary

MeasureTime frameDescription
prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotinNovember 15th, 2023Statistical analysis of data obtained by medical charts related to smoking attitude, obesity and concomitant medications in patients with metastatic UC treated with pembrolizumab or enfortumab vedotin

Countries

Italy

Contacts

Primary ContactMatteo Santoni, MD, PhD
mattymo@alice.it+39 07332572960
Backup ContactGiulia Sorgentoni
sorgentoni.giulia@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026