Status:

RECRUITING

ARON-2 Study-Multicentric International Retrospective Study

Lead Sponsor:

Matteo Santoni

Conditions:

Urothelial Carcinoma

Eligibility:

All Genders

18+ years

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-b...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

February 17 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2027

Estimated Enrollment :

367 Patients enrolled

Trial Details

Trial ID

NCT05290038

Start Date

February 17 2022

End Date

September 30 2027

Last Update

April 2 2025

Active Locations (1)

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1

Ospedale di Macerata, UOC Oncologia

Macerata, Macerata, Italy, 62100