Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study

Renal cell carcinoma (RCC) represents the seventh (men) respectively tenth (women) most frequent cancer in western countries. After one or more lines of VEGF-targeted therapy, immunotherapy with nivolumab is strongly recommended in patients with metastatic RCC. Nivolumab is the first, and so far, only approved PD-1immune checkpoint inhibitor to demonstrate a gain in overall survival in RCC. We describe herein design and rationale of trial CA209653 (NIS NORA'), a prospective, noninterventional cohort study investigating the effectiveness of nivolumab. This systematic collection of real-world effectiveness data will recruit 323patients with advanced RCC to provide a precise estimate for overall survival over a 5-year follow-up period (Trial registration: NCT02940639).