ARON-2 Study-Multicentric International Retrospective Study

Matteo Santoni

Status: Enrolling

Conditions: Urothelial Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05290038

ARON-2

Details and patient eligibility

About

The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.

Enrollment: 367 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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