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NCT Number: NCT05287464

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

Recruiting

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Key information

Conditions

Metastatic Renal Cell Carcinoma (mRCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Macerata, UOC Oncologia

Province of Macerata, Macerata, 62100, Italy

Location status: Recruiting

Location contact

Giulia Sorgentoni, PhD

CONTACT

[email protected]

+3907332573752

Matteo Santoni, MD, PhD

CONTACT

Matteo Santoni, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pembrolizumab plus axitinib

Drug

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

Other names: nivolumab plus cabozantinib, pembrolizumab plus lenvatinib, nivolumab plus ipilimumab, avelumab plus axitinib, atezolizumab plus bevacizumab

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: March 31th, 2022

  2. Overall Survival (OS)

    Time frame: March 31th, 2022

  3. Overall Response Rate (ORR)

    Time frame: March 31th, 2022

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Sorgentoni, PhD

CONTACT

[email protected]

Matteo Santoni, MD, PhD

CONTACT

[email protected]

+3907332572960

Sponsors and collaborators

Lead sponsor

Hospital of Macerata

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Mar 18, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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