Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The ARON-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced/metastatic Urothelial Cancer.
Two supplementary optional studies are designed: one is related to CT scans evaluation for 3D reconstruction analysis; the other one is an omic analysis on FFPE tissue.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| overall survival in patients with la/mUC or rare GU tumors | time from the start of the therapy until death from any cause | December 2030 |
| progression-free survival | time from the start of the therapy until progression or death from any cause. | December 2030 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of adverse event | Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. | December 2030 |
| Objective Response Rate (ORR) Based on RECIST v1.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Clinical and Pathological Covariates on Overall Survival (OS) as Measured by the Kaplan-Meier Method. | Evaluation of the prognostic significance of baseline characteristics-including smoking status (current/former vs. never), obesity (BMI ≥ 30 kg/m2), age, renal function (eGFR), primary tumor location (upper vs. lower tract), and concomitant medication use on Overall Survival. OS is defined as the time from the first dose of EV+P to death from any cause. OS will be estimated by the Kaplan-Meier method with Rothman's 95% Confidence Intervals (CI) and compared between subgroups using the log-rank test. To identify independent prognostic factors, univariable and multivariable analyses will be performed using Cox proportional hazards models, reporting Hazard Ratios (HR) and their corresponding 95% CIs. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult patients affected by locally advanced or metastatic urothelial cancer, or with rare genitourinary tumors, treated with enfortumab vedotin plus pembrolizumab
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Santoni, Medical Doctor | Contact | +39 | matteo.santoni82@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Matteo Santoni | Aron Research Foundation Ets | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Macerata | Province of Macerata | 62100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Objective Response Rate (ORR) is defined as the proportion of patients achieving either a Complete Response (CR) or a Partial Response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| December 2030 |
| December 2030 |