Eligibility for this study includes patients with (i) clear cell or sarcomatoid histologies, (ii) have undergone a nephrectomy, and (iii) be at high risk of recurrence (T2 Grade 4, T3a Grade 3-4, T3b/c any Grade, T4 any Grade or TxN+ any Grade) or have had complete resection of limited metachronous/synchronous metastasis. Additional criteria including ECOG performance status ≤1 and tumor specimens evaluable for PD-L1. The primary endpoint is independent review facility (IRF)-assessed disease-free survival (DFS), defined as the time from randomization to the first documented recurrence event (local recurrence, new primary RCC, distant metastasis) or death. Subjects will be randomized 1:1 to receive atezolizumab 1200 mg IV every 3 weeks or placebo IV every 3 weeks for 16 cycles or 1 year. Stratification will be by disease stage (T2/T3a vs T3b/c/T4/N+ vs metastasectomy), region (North America [excluding Mexico] vs rest of world), and PD-L1 status on tumor-infiltrating immune cells (IC; PD-L1 IC expression < 1% vs ≥ 1%). Secondary endpoints include (i) OS, (ii) investigator-assessed DFS, (iii) IRF-assessed and investigator-assessed DFS in patients with ≥ 1% PD-L1 IC, (iv) disease-specific survival, (v) distant metastasis-free survival, and (vi) the 3-year rates of IRF-assessed DFS and investigator-assessed DFS. The planned analysis will occur when at least 65% of patients in the two arms have died. Enrollment is currently ongoing, and the goal is for 664 patients will be enrolled at 200 sites in 27 countries.
Clinical trial: NCT03024996
Presented By: Robert Uzzo, Fox Chase Cancer Center, Philadelphia, PA, USA
Co-Authors: Axel Bex, Brian I. Rini, Laurence Albiges, Cristina Suarez, Frank Donaldson, Takashi Asakawa, Christina Schiff, Sumanta K. Pal
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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