Dr. Iacovelli on Eligibility Criteria of the ARIES Trial in Urothelial Cancer

Roberto Iacovelli, MD, PhD, medical oncologist, the Fondazione Policlinico Gemelli IRCCS, Rome, Italy, discusses the patient eligibility criteria of the phase 2 ARIES trial (NCT03891238) in urothelial cancer.

The ARIES trial evaluated first-line avelumab (Bavencio) in patients with metastatic and locally advanced urothelial cancer who were PD-L1 positive and unfit for cisplatin-based chemotherapy.

The ideal patient for the trial had to be cisplatin ineligible and have a low creatinine clearance, Iacovelli says. Other criteria included rapid progression within 6 months from the end of adjuvant or neoadjuvant cisplatin-based chemotherapy, Iacovelli adds. A patient’s ECOG performance status needed to be 2 or less, and patients were permitted to have measurable or unmeasurable disease, Iacovelli says.

PD-L1 expression set the ARIES trial apart from other studies in metastatic and locally advanced urothelial cancer. Prior to enrollment, patients were specifically screened for PD-L1 expression on tumor cells, and only patients with a PD-L1 expression greater than 5% were eligible, Iacovelli concludes.