International Multicentric Study ARON-1

November 19, 2025 updated by: Hospital of Macerata

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matteo Santoni, MD, PhD
  • Phone Number: +3907332572960
  • Email: mattymo@alice.it

Study Contact Backup

Study Locations

  • Italy
    • Macerata
      • Macerata, Macerata, Italy, 62100
        • Recruiting
        • Ospedale di Macerata, UOC Oncologia
        • Contact:
          • Matteo Santoni, MD, PhD
        • Contact:
        • Principal Investigator:
          • Matteo Santoni, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of immuno-combination in the elderly populaton
Time Frame: May 31th, 2022
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)
Time Frame: May 31th, 2022
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
Time Frame: May 31th, 2022
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
Time Frame: September 30th, 2022
Data on tumor assessment and response to therapy in non-clear RCC will be statistically analyzed
September 30th, 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of Macerata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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