Reviews past records of bladder cancer patients treated with pembrolizumab or enfortumab vedotin
Looks back at adults with urothelial carcinoma who received pembrolizumab or enfortumab vedotin.
Key facts
- Who runs it
- Matteo Santoni
- Where
- Province of Macerata, ItalySee the site
- Trial code
- Registry title
- ARON-2 Study-Multicentric International Retrospective Study
- Status
- Recruiting
- People taking part
- 367 people, planned
- Started
- 17 Feb 2022
- Expected to end
- 30 Sept 2027
- Type of study
- Observational
- Record updated
- 2 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial looks back at adults with metastatic urothelial cancer who were treated with pembrolizumab or enfortumab vedotin.
- Age
- Older than 18 years
- Sex
- All sexes
- Disease stage
- Urothelial carcinoma of the upper and/or lower urinary tract, with metastatic disease confirmed by tissue exam or imaging.
- Earlier treatment
- Pembrolizumab after earlier platinum-based chemotherapy, or as first treatment if platinum chemotherapy was not possible, with at least 1 cycle between 1 January 2018 and 30 November 2021. Or enfortumab vedotin after platinum-based chemotherapy and an anti-PD-1/PD-L1 inhibitor, with at least 1 cycle between June 1st 2022 and July 31st 2023.
Main reasons for not taking part
- No tissue-confirmed diagnosis of urothelial carcinoma
- No metastatic disease confirmed by tissue exam or imaging
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients without histologically or radiologically confirmed metastatic disease
- Patients without histologically confirmed diagnosis of UC
Where in Italy
- Ospedale di Macerata, UOC OncologiaProvince of Macerata, ItalyContact: Matteo Santoni, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- ARON-2 Study-Multicentric International Retrospective Study
- Plain-language title
- Reviews past records of bladder cancer patients treated with pembrolizumab or enfortumab vedotinGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV).Cancer immunology, immunotherapy : CII, 2026
- Record updated
- 2 April 2025