In this study, tumor biopsy prior to randomization is mandatory to ensure the correct diagnosis and will all unparalleled correlative science in this National Clinical Trials Network study. There will be 766 patients with clinical stage ≥T2 or any node positive M0 RCC of any histology will be enrolled. The study arm will receive nivolumab 240mg IV for 2 doses prior to surgery followed by nivolumab adjuvantly for 9 months (q2 weeks x 3 months followed by q4 weeks x 6 months). The control arm will undergo the current standard of care, surgical resection, followed by observation. Patients will be stratified by T stage, node positivity, and disease histology. The study is designed with 84.2% power to detect a 14.4% absolute increase in the primary endpoint of recurrence-free survival from the ASSURE historical control of 55.8% to 70.2% at 5 yrs (HR 0.70) . Additionally, the study is powered to detect a significant OS benefit (HR 0.67).
The authors conclude that PROSPER RCC exemplifies team science with a host of planned correlative work to investigate the significance of the baseline immune milieu and changes after neoadjuvant priming and to identify predictive gene expression patterns.
Clinical trial: NCT 03055013
Presented By: Lauren Christine Harshman, Dana-Farber Cancer Institute, Boston, MA, USA
Co-Authors: Maneka Puligandla, Naomi B. Haas, Mohamad Allaf, Charles G. Drake, David F. McDermott, Sabina Signoretti, David Cella, Rajan T Gupta, Rupal Satish Bhatt, Eliezer Mendel Van Allen, Toni K. Choueiri, Primo Lara, Anil Kapoor, Daniel Yick Chin Heng, Brian M. Shuch, Michael A.S. Jewett, Daniel J. George, M Dror Michaelson, Michael Anthony Carducci, On Behalf of the PROSPER RCC Investigators
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA
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