International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAron Research Foundation Ets
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >18years
Histologically confirmed diagnosis of la/mUC of upper and/or lower urinary tract or histologically confirmed diagnosis of rare GU tumors.
Histologically or radiologically confirmed metastatic disease
Patients treated with first-line EV+P combination
Disqualifiers
Patients without histologically confirmed diagnosis of UC
Patients without histologically or radiologically confirmed la or mUC
Trial population
adult patients affected by locally advanced or metastatic urothelial cancer, or with rare genitourinary tumors, treated with enfortumab vedotin plus pembrolizumab
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
overall survival in patients with la/mUC or rare GU tumors
time from the start of the therapy until death from any cause
Time frame
December 20302
progression-free survival
time from the start of the therapy until progression or death from any cause.
Time frame
December 2030Secondary outcomes
1
Evaluation of adverse event
Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Time frame
December 20302
Objective Response Rate (ORR) Based on RECIST v1.1
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.
Time frame
December 2030Other outcomes
1
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.
Time frame
December 2030Sponsors and contacts
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Source ClinicalTrials.gov
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