Urothelial CarcinomaNCT05290038
ARON-2 Study-Multicentric International Retrospective Study
An observational study of Urothelial Carcinoma, run by Matteo Santoni at 1 site in Italy.
Trial summary
The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 367 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 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 pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy, or patient treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
Who may be able to join
- Patients aged >18y
- Histologically confirmed diagnosis of UC of upper and/or lower urinary tract
- Histologically or radiologically confirmed metastatic disease
- Patients treated with at least one of the following:
- Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021
- Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023
Who cannot join
- Patients without histologically confirmed diagnosis of UC
- Patients without histologically or radiologically confirmed metastatic disease
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 contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Macerata, UOC Oncologia
Province of Macerata, Macerata, 62100
Matteo Santoni, MD, PhD
Giulia Sorgentoni, PhD, +3907332573752, sorgentoni.giulia@gmail.com
About this study
The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
- Conditions
- Urothelial Carcinoma
- Keywords
- immunotherapy, real world experience, efficacy of pembrolizumab, artificial intelligence technology, Artificial Neural Network
- Medical subject headings
- Carcinoma, Transitional Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
Measured: November 15th, 2023
Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
Measured: November 15th, 2023
Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
Measured: November 15th, 2023
Secondary outcomes (1)
prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin
Statistical analysis of data obtained by medical charts related to smoking attitude, obesity and concomitant medications in patients with metastatic UC treated with pembrolizumab or enfortumab vedotin
Measured: November 15th, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start17 Feb 2022
- Primary completion31 Dec 2023
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies 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
- Retrospective
- Enrolment
- 367 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matteo Santoni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matteo Santoni, Hospital of Macerata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290038
- Sponsor's protocol ID
- ARON-2
- Status last verified
- Mar 2025
- First submitted
- 22 Feb 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mollica V, Massari F, Fujita K, Giannatempo P, Grande E, Buttner T, Bourlon MT, Taha T, Fukuokaya W, Myint ZW, Pichler R, Binz K, Molina-Cerrillo J, Kopecky J, de Liano AG, Kucharz J, Fiala O, Matrana MR, Kopp RM, Di Civita MA, Zgura A, Ansari J, Kihnel R, De Felice F, Angel M, Monteiro FSM, Soares A, Urun Y, Buti S, Santini D, Santoni M. Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV). Cancer Immunol Immunother. 2026 Mar 24;75(4):119. doi: 10.1007/s00262-026-04328-9.
PubMed 41874648Rizzo M, Morelli F, Urun Y, Buti S, Park SH, Bourlon MT, Grande E, Massari F, Landmesser J, Poprach A, Takeshita H, Roviello G, Myint ZW, Popovic L, Soares A, Abahssain H, Giannatempo P, Molina-Cerrillo J, Incorvaia L, Salah S, Zeppellini A, Monteiro FSM, Porta C, Gupta S, Santoni M. Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience. Cancer Med. 2025 Feb;14(4):e70479. doi: 10.1002/cam4.70479.
PubMed 39980145
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARON-2 Study-Multicentric International Retrospective Study
- ClinicalTrials.gov ID
- NCT05290038
- Acronym / sponsor ID
- ARON-2
- Conditions
- Urothelial Carcinoma
- Keywords
- immunotherapy, real world experience, efficacy of pembrolizumab, artificial intelligence technology, Artificial Neural Network
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 367 participants (estimated)
- Lead sponsor
- Matteo SantoniUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 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-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy, or patient treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
Key inclusion criteria (6 listed)
- Patients aged >18y
- Histologically confirmed diagnosis of UC of upper and/or lower urinary tract
- Histologically or radiologically confirmed metastatic disease
- Patients treated with at least one of the following:
- Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021
Key exclusion criteria (2 listed)
- Patients without histologically confirmed diagnosis of UC
- Patients without histologically or radiologically confirmed metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
Time frame: November 15th, 2023
Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
Time frame: November 15th, 2023
Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
Time frame: November 15th, 2023
1 secondary outcome
prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin
Time frame: November 15th, 2023
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 2 Apr 2025.
- Derived from this study: PubMed 41874648Mollica V, Massari F, Fujita K, Giannatempo P, Grande E, Buttner T, Bourlon MT, Taha T, Fukuokaya W, Myint ZW, Pichler R, Binz K, Molina-Cerrillo J, Kopecky J, de Liano AG, Kucharz J, Fiala O, Matrana MR, Kopp RM, Di Civita MA, Zgura A, Ansari J, Kihnel R, De Felice F, Angel M, Monteiro FSM, Soares A, Urun Y, Buti S, Santini D, Santoni M. Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV). Cancer Immunol Immunother. 2026 Mar 24;75(4):119. doi: 10.1007/s00262-026-04328-9.
- Derived from this study: PubMed 39980145Rizzo M, Morelli F, Urun Y, Buti S, Park SH, Bourlon MT, Grande E, Massari F, Landmesser J, Poprach A, Takeshita H, Roviello G, Myint ZW, Popovic L, Soares A, Abahssain H, Giannatempo P, Molina-Cerrillo J, Incorvaia L, Salah S, Zeppellini A, Monteiro FSM, Porta C, Gupta S, Santoni M. Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience. Cancer Med. 2025 Feb;14(4):e70479. doi: 10.1002/cam4.70479.
- Individual participant dataSharing planned: No
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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 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 Urothelial Carcinoma, run by Matteo Santoni 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 6 inclusion and 2 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 2 Apr 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 (+39 07332572960, mattymo@alice.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin (time frame: November 15th, 2023). 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 NCT05290038, which also lists 2 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 2 Apr 2025.