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Recruiting

NCT Number: NCT05290038

ARON-2 Study-Multicentric International Retrospective Study

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.

Recruiting

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Key information

Conditions

Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Macerata, UOC Oncologia

Province of Macerata, Macerata, 62100, Italy

Location status: Recruiting

Location contact

Giulia Sorgentoni, PhD

CONTACT

[email protected]

+3907332573752

Matteo Santoni, MD, PhD

CONTACT

Matteo Santoni, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin

    Time frame: November 15th, 2023

  2. Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin

    Time frame: November 15th, 2023

  3. Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin

    Time frame: November 15th, 2023

Secondary outcomes

  1. prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin

    Time frame: November 15th, 2023

    Statistical 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

Study contacts

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

Giulia Sorgentoni

CONTACT

[email protected]

Matteo Santoni, MD, PhD

CONTACT

[email protected]

+39 07332572960

Sponsors and collaborators

Lead sponsor

Matteo Santoni

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Mar 22, 2022
Registry last updated
Apr 2, 2025

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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