Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. (May 2018)

• Record Type: Journal Article
• Authors: Bedke, Jens; Grimm, Marc-Oliver; Grünwald, Viktor
• Is Part Of: Future oncology. Volume 14:Number 11(2018)
• Page Start: 1023
• Page End: 1034
• Publication Date: 2018-05
• Subjects: effectiveness -- immune checkpoint inhibition -- immunotherapy -- nivolumab -- noninterventional study -- PD-1 -- renal cell carcinoma; Oncology -- Periodicals; 616.99405
• DOI: 10.2217/fon-2017-0637
• Languages: English
• ISSNs: 1479-6694

Abstract

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-1 immune 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 323 patients with advanced RCC to provide a precise estimate for overall survival over a 5-year follow-up period (Trial registration: NCT02940639).