International Multicentric Study ARON-1

Recruiting

• Conditions: Metastatic Renal Cell Carcinoma (mRCC)

• Registration Number: NCT05287464
• Lead Sponsor: Hospital of Macerata

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study Start: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Status Verified: 2024-06
• Primary Completion: 2024-06-01
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	March 31th, 2022
Overall Response Rate (ORR)	March 31th, 2022
Progression-Free Survival (PFS)	March 31th, 2022

Secondary Outcome Measures

Name	Time	Method
Efficacy of different immuno-combinations in patients with non-clear RCC	September 30th, 2022	Data on tumor assessment and response to therapy in non-clear RCC will be statistically analyzed
Efficacy of immuno-combination in the elderly populaton	May 31th, 2022	Data on tumor assessment and response to therapy on elderly populaton will be statistically analyzed
Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations	May 31th, 2022	Statistical analysis of prognostic role of smoking attitude and obesity in treated RCC patients
Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases)	May 31th, 2022	Data on tumor assessment and response to therapy will be statistically analyzed

Trial Locations

Locations (1)

Ospedale di Macerata, UOC Oncologia; 🇮🇹 Macerata, Italy