ARON-2 Study-Multicentric International Retrospective Study
Launched by MATTEO SANTONI · Mar 11, 2022
Trial Information
Current as of November 09, 2025
Recruiting
Keywords
ClinConnect Summary
The ARON-2 study is a research trial that looks at how well two different treatments work for patients with urothelial carcinoma, a type of cancer that affects the urinary system. Specifically, the study focuses on patients who were treated with pembrolizumab as their first treatment if they couldn’t tolerate standard chemotherapy, or as a second treatment for those whose cancer progressed after chemotherapy. Additionally, the study will also examine patients treated with enfortumab vedotin after their cancer worsened despite previous treatments.
To participate in this trial, individuals need to be at least 18 years old and have a confirmed diagnosis of urothelial carcinoma that has spread to other parts of the body. They must have received at least one cycle of either pembrolizumab or enfortumab vedotin during specific time frames. Participants can expect to contribute to important research that may improve treatment options for future patients with this type of cancer. It’s essential to note that only patients with confirmed metastatic disease are eligible for this study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Patients without histologically confirmed diagnosis of UC
- • Patients without histologically or radiologically confirmed metastatic disease
About Matteo Santoni
Matteo Santoni is a dedicated clinical trial sponsor focused on advancing medical research and therapeutic innovation. With a commitment to improving patient outcomes, the organization collaborates with leading healthcare professionals and research institutions to design and implement rigorous clinical studies. Matteo Santoni prioritizes ethical standards and regulatory compliance, ensuring the highest quality of data collection and analysis. Their mission is to accelerate the development of effective treatments while fostering a collaborative environment that prioritizes patient safety and scientific integrity.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Macerata, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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