International Multicentric Study ARON-1

Last updated: March 28, 2025
Sponsor: Hospital of Macerata
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

pembrolizumab plus axitinib

Clinical Study ID

NCT05287464
ARON-1
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged >18y

  • Cytological or Histologically confirmed diagnosis of clear cell or non-clear cellRCC

  • Histologically or radiologically confirmed diagnosis of metastatic disease

  • First-line treatment with nivolumab plus ipilimumab or nivolumab plus cabozantinibor pembrolizumab plus axitinib or pembrolizumab plus lenvatinib or avelumab plusaxitinib or atezolizumab plus bevacizumab

Exclusion

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 theInclusion Criteria Section

Study Design

Total Participants: 1220
Treatment Group(s): 1
Primary Treatment: pembrolizumab plus axitinib
Phase:
Study Start date:
March 10, 2022
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Ospedale di Macerata, UOC Oncologia

    Macerata, 62100
    Italy

    Active - Recruiting

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