International Multicentric Study ARON-1

Conditions

Metastatic Renal Cell Carcinoma (mRCC)

Keywords

immunotherapy, mRCC, immuno-combinations, artificial intelligence technology, real-world data

Brief summary

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

María T. Bourlon, Luca Galli, Enrique Grande, Se Hoon Park, Bohuslav Melichar et al. (31 authors)

Frontiers in Oncology2025-07-252 citations

10.3389/fonc.2025.1605282

Clinical features and response to immune combinations in patients with renal cell carcinoma and sarcomatoid de‐differentiation (ARON‐1 study)

Chiara Ciccarese, Thomas Büttner, Linda Cerbone, Ilaria Zampiva, Fernando Sabino Marques Monteiro et al. (35 authors)

International Journal of Cancer2024-09-078 citations

10.1002/ijc.35141

Papillary Renal Cell Carcinoma: Outcomes for Patients Receiving First-line Immune-based Combinations or Tyrosine Kinase Inhibitors from the ARON-1 Study.

Massari F, Mollica V, Fiala O, De Giorgi U, Kucharz J, Vitale MG, Molina-Cerrillo J, Facchini G, Seront E, Lenci E, Bourlon MT, Carrozza F, Pichler R, Lolli C, Myint ZW, Kanesvaran R, Torniai M, Rescigno P, Gomez de Liaño A, Zakopoulou R, Buti S, Porta C, Grande E, Santoni M.

2024-04-0410 citations

10.1016/j.euo.2024.03.011

Geographical differences in the management of metastatic de novo renal cell carcinoma in the era of immune-combinations.

Porta C, Bamias A, Zakopoulou R, Myint ZW, Cavasin N, Iacovelli R, Pichler M, Kopecky J, Kucharz J, Rizzo M, Galli L, Büttner T, DE Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Kopp RM, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Büchler T, Massari F, Mollica V, Seront E, Calabrò F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Caffo O, Procopio G, Sunela K, Bassanelli M, Ortega C, Grillone F, Landmesser J, Merler S, Messina C, Küronya Z, Mosca A, Bhuva D, Santini D, Vau N, Morelli F, Incorvaia L, Rebuzzi SE, Roviello G, Soares A, Zabalza IO, Rizzo A, Bisonni R, Pierantoni F, Sorgentoni G, Monteiro FS, Battelli N, Buti S, Santoni M.

2023-08-0112 citations

10.23736/s2724-6051.23.05369-7

Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study.

Santoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Rizzo M, Galli L, Büttner 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, Büchler T, Seront E, Calabrò 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, Küronya 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.

2023-06-2731 citations

10.1007/s11523-023-00978-2

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).

Santoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Salfi A, Büttner 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, Büchler T, Seront E, Calabrò 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, Küronya 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.

2023-03-2023 citations

10.1016/j.clgc.2023.03.006

Interventions

DRUGpembrolizumab plus axitinib

collect global experiences with the use of immuno-combinations in patients with metastatic RCC

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS)	March 31th, 2022
Overall Survival (OS)	March 31th, 2022
Overall Response Rate (ORR)	March 31th, 2022

Secondary

Measure	Time frame	Description
Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases)	May 31th, 2022	Data on tumor assessment and response to therapy will be statistically analyzed
Efficacy of different immuno-combinations in patients with non-clear RCC	September 30th, 2022	Data on tumor assessment and response to therapy in non-clear RCC will be statistically analyzed
Efficacy of immuno-combination in the elderly populaton	May 31th, 2022	Data on tumor assessment and response to therapy on elderly populaton will be statistically analyzed
Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations	May 31th, 2022	Statistical analysis of prognostic role of smoking attitude and obesity in treated RCC patients

Countries

Italy

Contacts

Primary ContactMatteo Santoni, MD, PhD

mattymo@alice.it+3907332572960

Backup ContactGiulia Sorgentoni, PhD

giulia.sorgentoni@libero.it

Outcome results

None listed