Phase 2 Randomized Study of Fianlimab, Cemiplimab, and Ipilimumab or Nivolumab Plus Ipilimumab in First-Line Advanced Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatment options for patients with advanced clear cell renal cell carcinoma RCC across all IMDC risk groups in this phase 2 randomized trial. The study compares three different drug combinations to understand their impact on the disease. This research aims to provide insights on first-line therapies for advanced RCC by assessing treatment responses over two years. Participants will be randomly assigned to one of three groups Arm A will receive cemiplimab, fianlimab, and ipilimumab together Arm B will receive cemiplimab and fianlimab and Arm C will receive the standard treatment of nivolumab and ipilimumab. All drugs are given intravenously, with specific schedules for combination and maintenance dosing. Treatment continues according to the assigned arm until disease progression or other study-defined criteria. During the study, participants will undergo regular assessments including imaging to measure tumor response, laboratory tests to monitor organ function, and evaluations of side effects. The main outcome is the objective response rate at two years, with additional measures including progression-free survival, duration of response, treatment-free survival, and adverse event rates monitored up to five years. Participants are followed closely with scheduled visits to track their health and treatment effects throughout the trial period.

A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)