In the phase Ⅲ Checkmate214 study, Nivolumab plus ipilimumab significantly improved overall survival (OS) and durable response with long time follow-up in IMDC intermediate/poor risk group advanced renal cell carcinoma (aRCC) patients, but there is limited evidence regarding the selection of patients responding to treatment. In this study, we investigated the treatment responsive patients among patients treated with nivolumab plus ipilimumab therapy.

aRCC patients who received nivolumab plus ipilimumab at Nippon Medical School were recruited. Treatment efficacy was evaluated based on RECIST ver1.1, and adverse events were evaluated using CTCAE ver5.0.

26 patients were identified. Median age was 66 years (41-85 years), 23 were male and 3 were female. 12 were unresectable, and 14 were metastatic. At the start of treatment, 16/10 cases were classified as intermediate/poor according to the IMDC classification, and 26 cases were classified as clear cell carcinoma pathologically. The median follow-up period was 45.9 months (range 3-114.6 months), and the median progression-free survival was 11.4 months (range 2.3-66.9 months). The maximum treatment effect after the start of treatment was CR/PR/SD/PD in 4/10/9/3 cases, and the response rate was 42.3% (moderate/poor=53.1%/21.0%). 8 cases had adverse events of grade 3 or higher, and four cases had irAEs requiring steroid administration. No adverse events of grade 4 or higher were observed. 6 patients are still undergoing treatment, and 4 patients have died.

Optimal treatment selection for advanced renal cell carcinoma remains controversial, but immunostaining maybe a factor. In this presentation, we will report on factors that influenced treatment, including a literature review.