852TiP - The PAZOREAL non-interventional study to assess efficacy and safety of pazopanib and everolimus in the changing metastatic renal cell carcinoma (mRCC) treatment landscape

Abstract

Renal cell carcinoma (RCC) is diagnosed in about 15,500 patients per year in Germany, with up to 60% of patients requiring systemic treatment in the metastatic setting. Vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin (mTOR) inhibitors are broadly used in mRCC therapy and sequential first-line pazopanib (VEGFR inhibitor) and second-line everolimus (mTOR inhibitor) is a standard treatment option. Nivolumab was recently approved in Europe for use after previous therapy. The non-interventional PAZOREAL study is designed to observe the real-world use of first-line through third-line therapy in the evolving treatment environment. Trial design: This is a prospective, non-interventional study that will evaluate the efficacy, tolerability, safety, and quality of life (QoL) in patients with mRCC treated with first-line pazopanib, second-line nivolumab or everolimus, or third-line everolimus after nivolumab. Adults with histologically confirmed mRCC of any subtype, who have a life expectancy of at least 6 months, and whose systemic treatment will either start with first-line pazopanib or continue with third-line everolimus after second-line nivolumab, are eligible. Treatment will follow the respective German drug labels. Patients' history, treatment, disease assessment, concomitant medication, adverse events, follow-up treatments, and survival will be documented. Variables will include the time on drug for documented therapies, overall survival, dosing parameters, safety, and QoL (assessed by EQ-5D-5L questionnaire). Recruitment of patients started in December 2015 and is planned to end in December 2018, with a goal of 450 documented patients at about 150 sites in Germany. Four interim analyses are planned, and the first analysis will be performed in April 2017. Immediately after approval of nivolumab in Germany, the study was opened for documentation of therapy sequences including in-label nivolumab treatment in the second-line setting. Legal entity responsible for the study: Novartis Pharma GmBH