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

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Renal Cell Cancer
Presenter Peter Goebell
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors P. Goebell1, C. Doehn2, C. Grüllich3, V. Grünwald4, T. Steiner5, R. Ehness6, M. Welslau7
  • 1Department Of Urology, University Erlangen, 91054 - Erlangen/DE
  • 2Department Of Urology, Urologikum Lübeck, Lübeck/DE
  • 3Department Of Medical Oncology, University of Heidelberg, Heidelberg/DE
  • 4Clinic For Hematology, Hemostasis, Oncology, And Stem Cell Transplantation, Medical School of Hannover, 30627 - Hannover/DE
  • 5Department Of Urology, HELIOS Klinikum Erfurt, Erfurt/DE
  • 6Department Of Oncology, Novartis Pharma GmbH, Nuernberg/DE
  • 7Onkologische Schwerpunktpraxis Am Klinikum, Onkologie Aschaffenburg, 63739 - Aschaffenburg/DE

Abstract

Background

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.

Clinical trial identification

Legal entity responsible for the study

Novartis Pharma GmBH

Funding

Novartis Pharma GmBH

Disclosure

P. Goebell: Advisory boards: Bayer, Bristol-Myers-Squibb, Novartis, Pfizer, Janssen, Sanofi-Aventis Honoraria, Travel: Astellas, Bayer, Bristol-Myers-Squibb, Novartis, Pfizer, Janssen, Sanofi-Aventis C. Doehn: Consulting/Advisory board: Roche Honoraria: Amgen, Bayer, BMS, Novartis, Pfizer Stock: AstraZeneca. C. Grüllich: Consulting/Advisory Board: Novartis, Nierenzell CA Honoraria: Novartis, Nierenzell CA Research: Novartis. T. Steiner: Consulting/Advisory Board: Novartis, BMS Research: BMS Studienteilnahe. R. Ehness: Employment: Novartis Germany Stock: GSK, Novartis. M. Welslau: Consulting/Advisory Board: Novartis, GSK, Pfizer, BMS Honoraria: Novartis, GSK, Pfizer, BMS. All other authors have declared no conflicts of interest.