Metastatic Renal Cell Carcinoma (mRCC) Clinical Trial
Official title:
International Multicentric Study ARON-1
| NCT number | NCT05287464 |
| Other study ID # | ARON-1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 10, 2022 |
| Est. completion date | December 31, 2024 |
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
| Status | Recruiting |
| Enrollment | 1220 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | June 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale di Macerata, UOC Oncologia | Macerata |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital of Macerata |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | March 31th, 2022 | ||
| Primary | Overall Survival (OS) | March 31th, 2022 | ||
| Primary | Overall Response Rate (ORR) | March 31th, 2022 | ||
| Secondary | Efficacy of immuno-combination in the elderly populaton | Data on tumor assessment and response to therapy on elderly populaton will be statistically analyzed | May 31th, 2022 | |
| Secondary | Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases) | Data on tumor assessment and response to therapy will be statistically analyzed | May 31th, 2022 | |
| Secondary | Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations | Statistical analysis of prognostic role of smoking attitude and obesity in treated RCC patients | May 31th, 2022 | |
| Secondary | Efficacy of different immuno-combinations in patients with non-clear RCC | Data on tumor assessment and response to therapy in non-clear RCC will be statistically analyzed | September 30th, 2022 |
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