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Roberto Iacovelli, MD, PhD, discusses the patient eligibility criteria of the phase 2 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.