Urothelial Carcinoma Clinical Trial
Official title:
ARON-2 Study-Multicentric International Retrospective Study
| NCT number | NCT05290038 |
| Other study ID # | ARON-2 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 17, 2022 |
| Est. completion date | January 31, 2024 |
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.
| Status | Recruiting |
| Enrollment | 367 |
| Est. completion date | January 31, 2024 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale di Macerata, UOC Oncologia | Macerata |
| Lead Sponsor | Collaborator |
|---|---|
| Matteo Santoni |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | ||
| Primary | Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | ||
| Primary | Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | ||
| Secondary | prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin | Statistical analysis of data obtained by medical charts related to smoking attitude, obesity and concomitant medications in patients with metastatic UC treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 |
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