International Multicentric Study ARON-1

Hospital of Macerata

Status: Enrolling

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Treatments: Drug: pembrolizumab plus axitinib

Study type: Observational

Funder types: Other

Identifiers

NCT05287464

ARON-1

Details and patient eligibility

About

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

Enrollment: 1,220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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