Menu
Recruiting NCT05287464

International Multicentric Study ARON-1

— Observational Metastatic Renal Cell Carcinoma (mRCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pembrolizumab plus axitinib.
Who it may be relevant to
Registry conditions: Metastatic Renal Cell Carcinoma (mRCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug pembrolizumab plus axitinib
    collect global experiences with the use of immuno-combinations in patients with metastatic RCC

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: March 31th, 2022]
  • Overall Survival (OS) [Time frame: March 31th, 2022]
  • Overall Response Rate (ORR) [Time frame: March 31th, 2022]
Secondary outcome measures (4)
  • Efficacy of immuno-combination in the elderly populaton [Time frame: May 31th, 2022]
  • Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases) [Time frame: May 31th, 2022]
  • Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations [Time frame: May 31th, 2022]
  • Efficacy of different immuno-combinations in patients with non-clear RCC [Time frame: September 30th, 2022]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Ospedale di Macerata, UOC Oncologia — Province of Macerata

Publications

  • Ciccarese C, Buttner T, Cerbone L, Zampiva I, Monteiro FSM, Basso U, Pichler M, Vitale MG, Fiala O, Roviello G, Kopp RM, Carrozza F, Pichler R, Grillone F, Calabuig EP, Zeppellini A, Kuronya Z, Galli L, Facchini G, Sunela K, Mosca A, Molina-Cerrillo J, Spinelli GP, Ansari J, Scala A, Mollica V, Grande E, Buti S, Kanesvaran R, Zakopoulou R, Bamias A, Rizzo M, Massari F, Iacovelli R, Santoni M. Clin PMID 39243397
  • 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, Ca PMID 37369815
  • 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 PMID 37062658

Identifiers

NCT: NCT05287464 · ARON-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗