Analysis of pembrolizumab and enfortumab vedotin in urothelial carcinoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ARON-2 study is a multicentric international retrospective analysis focusing on patients with urothelial carcinoma who have been treated with pembrolizumab or enfortumab vedotin. It aims to evaluate the efficacy of these treatments in patients who are either platinum-unfit or have progressed after platinum-based chemotherapy. The study will utilize artificial intelligence technology, specifically an Artificial Neural Network, to analyze real-world experiences and outcomes from these therapies. Data will be collected from patients treated between specified timeframes to assess treatment effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Ospedale di Macerata, UOC Oncologia
  Province of Macerata, Macerata, Italy Recruiting

Study contacts

• Study coordinator: Matteo Santoni, MD, PhD
• Email: mattymo@alice.it
• Phone: +39 07332572960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.