International Multicentric Study ARON-1

Study Overview
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Brief Summary
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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

Official Title
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International Multicentric Study ARON-1

Conditions
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Metastatic Renal Cell Carcinoma (mRCC)

Intervention / Treatment
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* Drug: pembrolizumab plus axitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pembrolizumab plus axitinib|collect global experiences with the use of immuno-combinations in patients with metastatic RCC|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | March 31th, 2022 | 
| Overall Survival (OS) |  | March 31th, 2022 | 
| Overall Response Rate (ORR) |  | March 31th, 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, mRCC, immuno-combinations, artificial intelligence technology, real-world data