Nivolumab may be safe and effective in patients with advanced treatment-refractory renal cell carcinoma (RCC), a new study published online early in the Journal of Clinical Oncology has shown.

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody approved by the U.S. Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma who experienced disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor, and patients with metastatic squamous non-small cell lung cancer who experienced progression on or after platinum-based chemotherapy.

For this phase 1 study, researchers enrolled 34 patients with previously treated advanced RCC between 2008 and 2012. Patients received nivolumab at a dose of 1mg/kg or 10mg/kg intravenously in an outpatient setting twice weekly for up to 96 weeks.

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Results showed that 29% of patients achieved an objective response with a median response duration of 12.9 months. In addition, nine additional patients demonstrated stable disease lasting more than 24 weeks. Among five patients who stopped treatment while in response, three continued to respond for at least 45 weeks. The median overall survival was 22.4 months, and 1-year, 2-year, and 3-year survival rates were 71%, 48%, and 44%, respectively.

In regard to safety, 18% of patients experienced reversible grade 3 or 4 treatment-related adverse events.

The authors conclude that the findings are encouraging, and ongoing clinical trials will further evaluate the effect of nivolumab on overall survival in patients previously treated advanced RCC.


  1. McDermott DF, Drake CG, Sznol M, et al. Survival, durable response, and long-term safety in patients with previously treated advanced renal cell carcinoma receiving nivolumab. J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1200/JCO.2014.58.1041.