RecruitingNCT05290038
ARON-2 Study-Multicentric International Retrospective Study
Sponsor
Matteo Santoni
Enrollment
367 participants
Start Date
Feb 17, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria2
- Patients without histologically confirmed diagnosis of UC
- Patients without histologically or radiologically confirmed metastatic disease
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05290038
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