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.
Study Type
OBSERVATIONAL
Enrollment
361
Ospedale di Macerata
Macerata, Italy
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 2030
progression-free survival
time from the start of the therapy until progression or death from any cause.
Time frame: December 2030
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 2030
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 2030
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