Phase II Trial Comparing Axitinib Plus Nivolumab Versus Nivolumab Alone After Nivolumab and Ipilimumab Induction in Patients with Metastatic Renal Cell Carcinoma

What this Trial Is About

This research evaluates whether adding axitinib to nivolumab maintenance treatment after initial therapy with nivolumab plus ipilimumab can improve response rates in patients with metastatic renal cell carcinoma mRCC who have not achieved a complete response or experienced disease progression. The study is a phase II, open-label trial that aims to increase partial response rates based on prior trial results. Participants are randomly assigned to one of two groups one group receives axitinib 5 mg twice daily orally in addition to nivolumab 480 mg intravenously every four weeks, while the other group continues with nivolumab alone at the same dose and schedule. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or physician decision. The trial plans to enroll 118 patients to detect meaningful differences between groups. Throughout the study, participants will be closely monitored with tumor assessments and health evaluations to measure outcomes such as progression-free survival, overall survival, depth and duration of response, and treatment-related adverse events. Follow-up includes tracking health status and life status from enrollment through treatment and up to 100 days after the last dose. The study is sponsored by Consorzio Oncotech and started in April 2023, with an estimated end date in April 2027.

Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients