The study was done to evaluate the safety and efficacy of ICI rechallenge in patients with mRCC.

69 patients in total were included in the study. 50 were males and 19 were females. The most common therapies received at ICI-1 were single-agent ICI or ICI in combination with targeted therapy, while at ICI-2, the most common therapies were single-agent ICI or dual ICI. Most patients discontinued ICI-1 owing to disease progression or toxic effects. The overall response rates at ICI-1 and ICI-2 were 37% and 23%, respectively. The likelihood of a response at ICI-2 was greatest among patients who had previously responded to ICI-1, although responses at ICI-2 were seen in those who had progressive disease as their best response following ICI-1 as well as in those who received single-agent ICI at ICI-2. Grade 3 or higher immune-related adverse events were seen in 18 patients and 11 patients at ICI-1 and ICI-2, respectively. There were no treatment-related deaths.

The study concluded that ICI rechallenge in patients with mRCC may be safe and reasonably efficacious, with an overall response rate of 23%.