Metastatic Renal Cell Carcinoma (mRCC)NCT05287464
International Multicentric Study ARON-1
An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Hospital of Macerata at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma (mRCC)
- What is being tested?
- pembrolizumab plus axitinib
- How many people
- 1,220 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2022to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with first-line immuno-combinations for metastatic RCC
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Sorgentoni, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Macerata, UOC Oncologia
Province of Macerata, Macerata, 62100
Matteo Santoni, MD, PhD
Giulia Sorgentoni, PhD, +3907332573752, giulia.sorgentoni@libero.it
About this study
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
- Conditions
- Metastatic Renal Cell Carcinoma (mRCC)
- Being tested
- pembrolizumab plus axitinib
- Keywords
- immunotherapy, mRCC, immuno-combinations, artificial intelligence technology, real-world data
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumab plus axitinibDrug
Also called nivolumab plus cabozantinib, pembrolizumab plus lenvatinib, nivolumab plus ipilimumab, avelumab plus axitinib
collect global experiences with the use of immuno-combinations in patients with metastatic RCC
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: March 31th, 2022
Overall Survival (OS)
Measured: March 31th, 2022
Overall Response Rate (ORR)
Measured: March 31th, 2022
Secondary outcomes (4)
Efficacy of immuno-combination in the elderly populaton
Data on tumor assessment and response to therapy on elderly populaton will be statistically analyzed
Measured: 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
Measured: 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
Measured: 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
Measured: September 30th, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start10 Mar 2022
- Primary completion1 Jun 2024
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell Carcinoma (mRCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Macerata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287464
- Sponsor's protocol ID
- ARON-1
- Status last verified
- Nov 2025
- First submitted
- 28 Feb 2022
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ciccarese C, Buttner T, Cerbone L, Zampiva I, Monteiro FSM, Basso U, Pichler M, Vitale MG, Fiala O, Roviello G, Kopp RM, Carrozza F, Pichler R, Grillone F, Calabuig EP, Zeppellini A, Kuronya Z, Galli L, Facchini G, Sunela K, Mosca A, Molina-Cerrillo J, Spinelli GP, Ansari J, Scala A, Mollica V, Grande E, Buti S, Kanesvaran R, Zakopoulou R, Bamias A, Rizzo M, Massari F, Iacovelli R, Santoni M. Clinical features and response to immune combinations in patients with renal cell carcinoma and sarcomatoid de-differentiation (ARON-1 study). Int J Cancer. 2024 Dec 1;155(11):2036-2046. doi: 10.1002/ijc.35141. Epub 2024 Sep 7.
PubMed 39243397Santoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Rizzo M, Galli L, Buttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Buchler T, Seront E, Calabro F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Bamias A, Caffo O, Procopio G, Bassanelli M, Merler S, Messina C, Kuronya Z, Mosca A, Bhuva D, Vau N, Incorvaia L, Rebuzzi SE, Roviello G, Zabalza IO, Rizzo A, Mollica V, Sorgentoni G, Monteiro FSM, Montironi R, Battelli N, Porta C. Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study. Target Oncol. 2023 Jul;18(4):559-570. doi: 10.1007/s11523-023-00978-2. Epub 2023 Jun 27.
PubMed 37369815Santoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Salfi A, Buttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Buchler T, Seront E, Calabro F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Zakopoulou R, Caffo O, Procopio G, Bassanelli M, Zampiva I, Messina C, Kuronya Z, Mosca A, Bhuva D, Vau N, Incorvaia L, Rebuzzi SE, Roviello G, Zabalza IO, Rizzo A, Mollica V, Catalini I, Monteiro FSM, Montironi R, Battelli N, Rizzo M, Porta C. Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1). Clin Genitourin Cancer. 2023 Oct;21(5):e309-e319.e1. doi: 10.1016/j.clgc.2023.03.006. Epub 2023 Mar 20.
PubMed 37062658
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentric Study ARON-1
- ClinicalTrials.gov ID
- NCT05287464
- Acronym / sponsor ID
- ARON-1
- Conditions
- Metastatic Renal Cell Carcinoma (mRCC)
- Keywords
- immunotherapy, mRCC, immuno-combinations, artificial intelligence technology, real-world data
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- Hospital of MacerataUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with first-line immuno-combinations for metastatic RCC
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumab plus axitinibAlso: nivolumab plus cabozantinib, pembrolizumab plus lenvatinib, nivolumab plus ipilimumab, avelumab plus axitinibcollect global experiences with the use of immuno-combinations in patients with metastatic RCC | Drug | – |
Primary outcome
Progression-Free Survival (PFS)
Time frame: March 31th, 2022
Overall Survival (OS)
Time frame: March 31th, 2022
Overall Response Rate (ORR)
Time frame: March 31th, 2022
4 secondary outcomes
Efficacy of immuno-combination in the elderly populaton
Time frame: May 31th, 2022
Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases)
Time frame: May 31th, 2022
Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations
Time frame: May 31th, 2022
Efficacy of different immuno-combinations in patients with non-clear RCC
Time frame: September 30th, 2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 39243397Ciccarese C, Buttner T, Cerbone L, Zampiva I, Monteiro FSM, Basso U, Pichler M, Vitale MG, Fiala O, Roviello G, Kopp RM, Carrozza F, Pichler R, Grillone F, Calabuig EP, Zeppellini A, Kuronya Z, Galli L, Facchini G, Sunela K, Mosca A, Molina-Cerrillo J, Spinelli GP, Ansari J, Scala A, Mollica V, Grande E, Buti S, Kanesvaran R, Zakopoulou R, Bamias A, Rizzo M, Massari F, Iacovelli R, Santoni M. Clinical features and response to immune combinations in patients with renal cell carcinoma and sarcomatoid de-differentiation (ARON-1 study). Int J Cancer. 2024 Dec 1;155(11):2036-2046. doi: 10.1002/ijc.35141. Epub 2024 Sep 7.
- Derived from this study: PubMed 37369815Santoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Rizzo M, Galli L, Buttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Buchler T, Seront E, Calabro F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Bamias A, Caffo O, Procopio G, Bassanelli M, Merler S, Messina C, Kuronya Z, Mosca A, Bhuva D, Vau N, Incorvaia L, Rebuzzi SE, Roviello G, Zabalza IO, Rizzo A, Mollica V, Sorgentoni G, Monteiro FSM, Montironi R, Battelli N, Porta C. Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study. Target Oncol. 2023 Jul;18(4):559-570. doi: 10.1007/s11523-023-00978-2. Epub 2023 Jun 27.
- Derived from this study: PubMed 37062658Santoni M, Massari F, Myint ZW, Iacovelli R, Pichler M, Basso U, Kopecky J, Kucharz J, Buti S, Salfi A, Buttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Buchler T, Seront E, Calabro F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Zakopoulou R, Caffo O, Procopio G, Bassanelli M, Zampiva I, Messina C, Kuronya Z, Mosca A, Bhuva D, Vau N, Incorvaia L, Rebuzzi SE, Roviello G, Zabalza IO, Rizzo A, Mollica V, Catalini I, Monteiro FSM, Montironi R, Battelli N, Rizzo M, Porta C. Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1). Clin Genitourin Cancer. 2023 Oct;21(5):e309-e319.e1. doi: 10.1016/j.clgc.2023.03.006. Epub 2023 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulia Sorgentoni, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Hospital of Macerata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Santoni, MD, PhD (+3907332572960, mattymo@alice.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: March 31th, 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287464, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.