International Multicentric Study ARON-1

NCT05287464 | Recruiting FDA Drug

• 1 other identifier: ARON-1
• Study Type: observational
• Target: 1,220
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Renal Cell Carcinoma (mRCC)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Progression-Free Survival (PFS)

  March 31th, 2022

• Overall Survival (OS)

  March 31th, 2022

• Overall Response Rate (ORR)

  March 31th, 2022

Secondary Outcomes (4)

• Efficacy of immuno-combination in the elderly populaton

  May 31th, 2022

• Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases)

  May 31th, 2022

• Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations

  May 31th, 2022

• Efficacy of different immuno-combinations in patients with non-clear RCC

  September 30th, 2022

Interventions

pembrolizumab plus axitinib DRUG

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

Also known as: nivolumab plus cabozantinib, pembrolizumab plus lenvatinib, nivolumab plus ipilimumab, avelumab plus axitinib, atezolizumab plus bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients without histologically confirmed diagnosis of RCC
• Patients without histologically or radiologically confirmed metastatic disease

Sponsors & Collaborators

• Hospital of Macerata: lead

Study Sites (1)

Ospedale di Macerata, UOC Oncologia

Macerata, Macerata, 62100, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 37369815 DERIVED

• 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.

  PMID: 37062658 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pembrolizumab; Axitinib; Nivolumab; cabozantinib; lenvatinib; Ipilimumab; avelumab; atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Matteo Santoni, MD, PhD

CONTACT

+3907332572960; mattymo@alice.it

Giulia Sorgentoni, PhD

CONTACT

giulia.sorgentoni@libero.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: March 10, 2022
• Primary Completion: June 1, 2024
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

IT (1)