NCT05290038Recruiting
ARON-2 Study-Multicentric International Retrospective Study
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 367 (estimated)
- First submitted
- 22 Feb 2022
- Start date
- 17 Feb 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Matteo Santoni
- Diseases
- Bladder cancer
- NCT number
- NCT05290038
What you commit to
- Study type: Observational
- Planned participants: 367
- From 17 Feb 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients without histologically or radiologically confirmed metastatic disease
Other
- Patients without histologically confirmed diagnosis of UC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale di Macerata, UOC Oncologia Coordinator of this site? Confirm its status | Province of Macerata | Italy | Recruiting |
Related publications
- Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV).Cancer Immunol Immunother · 2026 · PMID 41874648
This page is information, not medical advice. Discuss any trial with your doctor.