International Multicentric Study ARON-1

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Renal Cell Carcinoma (mRCC)
• Intervention / Treatment: Drug: pembrolizumab plus axitinib

• Study Type: Observational
• Enrollment (Estimated): 1220

Contacts and Locations

• Study Contact: Name: Matteo Santoni, MD, PhD; Phone Number: +3907332572960; Email: mattymo@alice.it
• Study Contact Backup: Name: Giulia Sorgentoni, PhD; Email: giulia.sorgentoni@libero.it

Study Locations

• Italy
  • Macerata
    • Macerata, Macerata, Italy, 62100
      • Recruiting
      • Ospedale di Macerata, UOC Oncologia
      • Contact: Matteo Santoni, MD, PhD
      • Contact: Giulia Sorgentoni, PhD; Phone Number: +3907332573752; Email: giulia.sorgentoni@libero.it
      • Principal Investigator: Matteo Santoni, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients treated with first-line immuno-combinations for metastatic RCC

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital of Macerata

Publications and helpful links

General Publications

• Santoni 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.
• Santoni 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: immunotherapy; mRCC; real-world data; immuno-combinations; artificial intelligence technology
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Amides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Benzene Derivatives; Acids, Carbocyclic; Benzoates; Benzamides; Indazoles; Pyrazoles; Nivolumab; Bevacizumab; Axitinib; Ipilimumab; pembrolizumab; atezolizumab; avelumab; cabozantinib; lenvatinib
• Other Study ID Numbers: ARON-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes