Romano Di Lombardia

Researchers are evaluating whether adding axitinib to nivolumab maintenance therapy after induction with nivolumab plus ipilimumab can improve treatment response in patients with metastatic renal cell carcinoma (mRCC). This phase II, open-label trial involves patients who completed induction therapy without achieving complete response or progressive disease. The goal is to increase the rate of partial responses from about 30% to 50%, based on results from previous trials. Participants are randomly assigned in a 1:1 ratio to receive either axitinib plus nivolumab or nivolumab alone. Axitinib is given at a standard dose of 5 mg twice daily, and nivolumab is administered intravenously at 480 mg every four weeks. Treatment continues until disease progression, unacceptable side effects, patient choice, or physician decision. The study plans to enroll 118 patients, with 59 in each treatment arm. During the trial, patients will undergo regular assessments including tumor measurements following RECIST criteria, laboratory tests, and evaluations of organ function and performance status. Researchers will monitor treatment efficacy by tracking the time until disease progression or death. Safety and tolerability will be closely observed, and patients must agree to contraception measures if applicable. The study aims to provide detailed information on the benefits and risks of adding axitinib to nivolumab maintenance therapy in mRCC.