Collecting global experiences with immunotherapy for metastatic kidney cancer
International Multicentric Study ARON-1
This study is collecting information from people with advanced kidney cancer who have received certain immunotherapy combinations to see how well these treatments work in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital of Macerata Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, pembrolizumab, avelumab, atezolizumab, bevacizumab, cabozantinib, axitinib, lenvatinib |
| Locations | 1 site (Province of Macerata, Macerata) |
| Trial ID | NCT05287464 on ClinicalTrials.gov |
What this trial studies
The ARON-1 Study is an international multicentric observational study aimed at gathering real-world data on the use of immuno-combinations in patients with metastatic renal cell carcinoma (mRCC). It includes two supplementary studies: ARON-1α, which investigates genomic signatures from tumor samples of patients treated with first-line immuno-combinations, and ARON-1β, which characterizes immune cell populations and their relationship with clinical outcomes. The study focuses on patients who have received specific combinations of immunotherapy treatments. By analyzing this data, the study aims to enhance understanding of treatment efficacy and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with a confirmed diagnosis of metastatic renal cell carcinoma who have received specific first-line immunotherapy combinations.
Not a fit: Patients without a confirmed diagnosis of metastatic renal cell carcinoma or those treated with non-specified immunotherapy combinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of immunotherapy combinations for treating metastatic renal cell carcinoma.
How similar studies have performed: Other studies have shown promise in using immunotherapy combinations for mRCC, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Province of Macerata, Macerata
- Ospedale di Macerata, UOC Oncologia — Province of Macerata, Macerata, Italy (Recruiting)
Study contacts
- Study coordinator: Matteo Santoni, MD, PhD
- Email: mattymo@alice.it
- Phone: +3907332572960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.