ARON-2 Study-Multicentric International Retrospective Study

Last updated: March 28, 2025
Sponsor: Matteo Santoni
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT05290038
ARON-2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-basedchemotherapy or as first-line therapy in patients platinum-unfit, and at least 1cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021

  • Treatment with enfortumab vedotin in patients progressed to previous platinum-basedchemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumabvedotin within the period from June 1st 2022 to July 31st 2023

Exclusion

Exclusion Criteria:

  • Patients without histologically confirmed diagnosis of UC

  • Patients without histologically or radiologically confirmed metastatic disease

Study Design

Total Participants: 367
Study Start date:
February 17, 2022
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Ospedale di Macerata, UOC Oncologia

    Macerata, 62100
    Italy

    Active - Recruiting

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