Clinical trial · Observational
International Multicentric Study ARON-1
- 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-1 Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of immuno-combinations in patients with metastatic RCC. Two Supplementary Studies (ARON-1α and ARON-1β) have been designed. The ARON-1α Supplementary Study has been designed to investigate for the presence of genomic signatures from tumor samples of patients treated with first-line immuno-combinations for advanced RCC. The ARON-1β Supplementary Study has been designed to charaterize the immune cell populations and assess their relationship with the clinical outcome of mRCC patients treated with first-line immuno-combinations
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 |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pembrolizumab plus axitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- March 31th, 2022
- measure
- Overall Survival (OS)
- timeFrame
- March 31th, 2022
- measure
- Overall Response Rate (ORR)
- timeFrame
- March 31th, 2022
Secondary outcomes (4)
- measure
- Efficacy of immuno-combination in the elderly populaton
- timeFrame
- May 31th, 2022
- description
- Data on tumor assessment and response to therapy on elderly populaton will be statistically analyzed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \>18y * Cytological or Histologically confirmed diagnosis of clear cell or non-clear cell RCC * Histologically or radiologically confirmed diagnosis of metastatic disease * First-line treatment with nivolumab plus ipilimumab or nivolumab plus cabozantinib or pembrolizumab plus axitinib or pembrolizumab plus lenvatinib or avelumab plus axitinib or atezolizumab plus bevacizumab Exclusion Criteria: * Patients without histologically confirmed diagnosis of RCC * Patients without histologically or radiologically confirmed metastatic disease * Patients treated with immuno-combinations not included in the list reported in the Inclusion Criteria Section
References
Publications (3)
- DERIVEDCiccarese C, Buttner T, Cerbone L, Zampiva I, Monteiro FSM, Basso U, Pichler M, Vitale MG, Fiala O, Roviello G, Kopp RM, Carrozza F, Pichler R, Grillone F, Calabuig EP, Zeppellini A, Kuronya Z, Galli L, Facchini G, Sunela K, Mosca A, Molina-Cerrillo J, Spinelli GP, Ansari J, Scala A, Mollica V, Grande E, Buti S, Kanesvaran R, Zakopoulou R, Bamias A, Rizzo M, Massari F, Iacovelli R, Santoni M. Clinical features and response to immune combinations in patients with renal cell carcinoma and sarcomatoid de-differentiation (ARON-1 study). Int J Cancer. 2024 Dec 1;155(11):2036-2046. doi: 10.1002/ijc.35141. Epub 2024 Sep 7. PMID 39243397
- DERIVEDSantoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Rizzo M, Galli L, Buttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Buchler T, Seront E, Calabro F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Bamias A, Caffo O, Procopio G, Bassanelli M, Merler S, Messina C, Kuronya Z, Mosca A, Bhuva D, Vau N, Incorvaia L, Rebuzzi SE, Roviello G, Zabalza IO, Rizzo A, Mollica V, Sorgentoni G, Monteiro FSM, Montironi R, Battelli N, Porta C. Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study. Target Oncol. 2023 Jul;18(4):559-570. doi: 10.1007/s11523-023-00978-2. Epub 2023 Jun 27. PMID 37369815
- DERIVEDSantoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Salfi A, Buttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Buchler T, Seront E, Calabro F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Zakopoulou R, Caffo O, Procopio G, Bassanelli M, Zampiva I, Messina C, Kuronya Z, Mosca A, Bhuva D, Vau N, Incorvaia L, Rebuzzi SE, Roviello G, Zabalza IO, Rizzo A, Mollica V, Catalini I, Monteiro FSM, Montironi R, Battelli N, Rizzo M, Porta C. Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1). Clin Genitourin Cancer. 2023 Oct;21(5):e309-e319.e1. doi: 10.1016/j.clgc.2023.03.006. Epub 2023 Mar 20.