Locally Advanced or Metastatic Urothelial CancerARON-2PLUSNCT07420855
International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC
An observational study of Locally Advanced or Metastatic Urothelial Cancer and Urothelial Cancer, run by Aron Research Foundation Ets at 1 site in Italy.
Trial summary
The ARON-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced/metastatic Urothelial Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Urothelial Cancer, Urothelial Cancer
- How many people
- 361 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Dec 2030
- 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: adult patients affected by locally advanced or metastatic urothelial cancer, or with rare genitourinary tumors, treated with enfortumab vedotin plus pembrolizumab
Who may be able to join
- Patients aged >18years
- Histologically confirmed diagnosis of la/mUC of upper and/or lower urinary tract or histologically confirmed diagnosis of rare GU tumors.
- Histologically or radiologically confirmed metastatic disease
- Patients treated with first-line EV+P combination
Who cannot join
- Patients without histologically confirmed diagnosis of UC
- Patients without histologically or radiologically confirmed la or mUC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Ospedale di Macerata
Province of Macerata, 62100
Matteo Santoni, +39, matteo.santoni82@gmail.com
About this study
Official title: International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced/Metastatic Urothelial Cancer (ARON-2PLUS)
The ARON-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced/metastatic Urothelial Cancer.
Two supplementary optional studies are designed: one is related to CT scans evaluation for 3D reconstruction analysis; the other one is an omic analysis on FFPE tissue.
- Keywords
- urothelial cancer, pembrolizumab, enfortumab vedotin, rare genitourinary tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival in patients with la/mUC or rare GU tumors
time from the start of the therapy until death from any cause
Measured: December 2030
progression-free survival
time from the start of the therapy until progression or death from any cause.
Measured: December 2030
Secondary outcomes (2)
Evaluation of adverse event
Treatment related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Measured: December 2030
Objective Response Rate (ORR) Based on RECIST v1.1
The Objective Response Rate (ORR) is defined as the proportion of patients achieving either a Complete Response (CR) or a Partial Response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: December 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Urothelial CancerStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 361 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aron Research Foundation Ets
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Santoni, Principal investigator, Aron Research Foundation Ets
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420855
- Sponsor's protocol ID
- ARON-2PLUS
- Acronym
- ARON-2PLUS
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced/Metastatic Urothelial Cancer (ARON-2PLUS)
- ClinicalTrials.gov ID
- NCT07420855
- Acronym / sponsor ID
- ARON-2PLUS / ARON-2PLUS
- Keywords
- urothelial cancer, pembrolizumab, enfortumab vedotin, rare genitourinary tumors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 361 participants (estimated)
- Lead sponsor
- Aron Research Foundation EtsUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Feb 2026 (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-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced/metastatic Urothelial Cancer.
Two supplementary optional studies are designed: one is related to CT scans evaluation for 3D reconstruction analysis; the other one is an omic analysis on FFPE tissue.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients affected by locally advanced or metastatic urothelial cancer, or with rare genitourinary tumors, treated with enfortumab vedotin plus pembrolizumab
Key inclusion criteria (4 listed)
- Patients aged >18years
- Histologically confirmed diagnosis of la/mUC of upper and/or lower urinary tract or histologically confirmed diagnosis of rare GU tumors.
- Histologically or radiologically confirmed metastatic disease
- Patients treated with first-line EV+P combination
Key exclusion criteria (2 listed)
- Patients without histologically confirmed diagnosis of UC
- Patients without histologically or radiologically confirmed la or mUC
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 in patients with la/mUC or rare GU tumors
Time frame: December 2030
time from the start of the therapy until death from any cause
progression-free survival
Time frame: December 2030
time from the start of the therapy until progression or death from any cause.
2 secondary outcomes
Evaluation of adverse event
Time frame: December 2030
Objective Response Rate (ORR) Based on RECIST v1.1
Time frame: December 2030
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 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced or Metastatic Urothelial Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
Active, not recruitingPhase 2
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Metastatic Urothelial Cancer
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
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.
Matteo Santoni principal investigator
Aron Research Foundation Ets
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 Locally Advanced or Metastatic Urothelial Cancer and Urothelial Cancer, run by Aron Research Foundation Ets 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 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: opening soon, as of the sponsor's last update on 19 Feb 2026. 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, Medical Doctor (+39, matteo.santoni82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival in patients with la/mUC or rare GU tumors (time frame: December 2030). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026.