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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | |
| Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | |
| Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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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, or patient treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Santoni, MD, PhD | Contact | +39 07332572960 | mattymo@alice.it | |
| Giulia Sorgentoni | Contact | sorgentoni.giulia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Macerata, UOC Oncologia | Recruiting | Province of Macerata | Macerata | 62100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41874648 | Derived | Mollica V, Massari F, Fujita K, Giannatempo P, Grande E, Buttner T, Bourlon MT, Taha T, Fukuokaya W, Myint ZW, Pichler R, Binz K, Molina-Cerrillo J, Kopecky J, de Liano AG, Kucharz J, Fiala O, Matrana MR, Kopp RM, Di Civita MA, Zgura A, Ansari J, Kihnel R, De Felice F, Angel M, Monteiro FSM, Soares A, Urun Y, Buti S, Santini D, Santoni M. Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV). Cancer Immunol Immunother. 2026 Mar 24;75(4):119. doi: 10.1007/s00262-026-04328-9. | |
| 39980145 |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Derived |
| Rizzo M, Morelli F, Urun Y, Buti S, Park SH, Bourlon MT, Grande E, Massari F, Landmesser J, Poprach A, Takeshita H, Roviello G, Myint ZW, Popovic L, Soares A, Abahssain H, Giannatempo P, Molina-Cerrillo J, Incorvaia L, Salah S, Zeppellini A, Monteiro FSM, Porta C, Gupta S, Santoni M. Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience. Cancer Med. 2025 Feb;14(4):e70479. doi: 10.1002/cam4.70479. |