Ospedale di Macerata
Province of Macerata, 62100, Italy
NCT Number: NCT07420855
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Province of Macerata, 62100, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: December 2030
time from the start of the therapy until death from any cause
Time frame: December 2030
time from the start of the therapy until progression or death from any cause.
Time frame: December 2030
Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Time frame: December 2030
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 2030
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.
Contact information is provided by the study sponsor or research team.
Aron Research Foundation Ets
Other
International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced/Metastatic Urothelial Cancer (ARON-2PLUS)
Acronym: ARON-2PLUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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