NCT05290038

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2022Sep 2027

Study Start

First participant enrolled

February 17, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

February 22, 2022

Last Update Submit

March 28, 2025

Conditions

Urothelial Carcinoma

Keywords

immunotherapyreal world experienceefficacy of pembrolizumabartificial intelligence technologyArtificial Neural Network

Outcome Measures

Primary Outcomes (3)

  • Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin

    November 15th, 2023

  • Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin

    November 15th, 2023

  • Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin

    November 15th, 2023

Secondary Outcomes (1)

  • prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin

    November 15th, 2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients without histologically confirmed diagnosis of UC
  • Patients without histologically or radiologically confirmed metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Macerata, UOC Oncologia

Macerata, Macerata, 62100, Italy

RECRUITING

Related Publications (1)

  • Rizzo 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.

    PMID: 39980145DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Matteo Santoni, MD, PhD

CONTACT

+39 07332572960mattymo@alice.it

Giulia Sorgentoni

CONTACT

sorgentoni.giulia@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Oncologist

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 22, 2022

Study Start

February 17, 2022

Primary Completion

December 31, 2023

Study Completion (Estimated)

September 30, 2027

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)