Nivolumab alone and in combination with ipilimumab is used for the treatment of patients with metastatic renal cell carcinoma (RCC). However, most patients with non-clear cell RCC are excluded from clinical trials, and there is limited data on the effectiveness of nivolumab for the treatment of these patients. This phase IIIb/IV CheckMate 374 study was conducted to look at the safety and efficacy of nivolumab in patients with previously treated advanced/metastatic RCC. The study was divided into three groups of patients; patients with clear cell RCC, patients with non-clear cell RCC, or those with brain metastases. This article reports on the safety and efficacy of nivolumab in patients with advanced non-clear cell RCC.
Forty-four patients were included in the study; 24 had papillary RCC, 7 had chromophobe RCC, 8 patients were unclassified, and 5 had other non-clear cell RCC histologies. The patients were followed for a median of 11 months. There were no severe or life-threatening adverse events and no deaths. Overall response rate was 13.6%, with 1 complete response (chromophobe) and 5 partial responses (papillary [n = 2], chromophobe [n = 1], collecting duct [n = 1], and unclassified [n = 1] histology). Median progression-free survival was 2.2 months and median overall survival was 16.3 months.
This study shows that the safety of nivolumab is consistent with previous studies and nivolumab was clinically effective in patients with advanced non-clear cell RCC, a patient population with high unmet need.