Analysis of pembrolizumab and enfortumab vedotin in urothelial carcinoma patients
ARON-2 Study-Multicentric International Retrospective Study
This study is testing how well the treatments pembrolizumab and enfortumab vedotin work for patients with urothelial carcinoma who can't take platinum-based chemotherapy or have not improved after it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 367 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital of Macerata Academic / other |
| Drugs / interventions | pembrolizumab, enfortumab, chemotherapy |
| Locations | 1 site (Province of Macerata, Macerata) |
| Trial ID | NCT05290038 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 18 years old with a histologically confirmed diagnosis of metastatic urothelial carcinoma who have received pembrolizumab or enfortumab vedotin.
Not a fit: Patients without a confirmed diagnosis of urothelial carcinoma or those without metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of pembrolizumab and enfortumab vedotin for patients with urothelial carcinoma, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in urothelial carcinoma, indicating potential for success in this analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Province of Macerata, Macerata
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.