Clinical trial · Observational
ARON-2 Study-Multicentric International Retrospective Study
NCT05290038CI-TRIAL-00088029recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
- timeFrame
- November 15th, 2023
- measure
- Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
- timeFrame
- November 15th, 2023
- measure
- Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
- timeFrame
- November 15th, 2023
Secondary outcomes (1)
- measure
- prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin
- timeFrame
- November 15th, 2023
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMollica 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. PMID 41874648
- DERIVEDRizzo 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. PMID 39980145