International Multicentric Study ARON-1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital of Macerata
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
patients treated with first-line immuno-combinations for metastatic RCC
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
pembrolizumab plus axitinib
Drugcollect global experiences with the use of immuno-combinations in patients with metastatic RCC
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Time frame
March 31th, 20222
Overall Survival (OS)
Time frame
March 31th, 20223
Overall Response Rate (ORR)
Time frame
March 31th, 2022Secondary outcomes
1
Efficacy of immuno-combination in the elderly populaton
Data on tumor assessment and response to therapy on elderly populaton will be statistically analyzed
Time frame
May 31th, 20222
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
Time frame
May 31th, 20223
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
Time frame
May 31th, 20224
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
Time frame
September 30th, 2022Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov