Trial design: Key inclusion criteria for this trial include: (i) age ≥18 years, (ii) histologically confirmed RCC with a clear cell component, (iii) T2 grade 4, T3, T4, N (+), or stage M1 with no evidence of disease following nephrectomy and/or metastasectomy (iv) no prior systemic therapy for advanced RCC, (v) disease-free following complete or partial nephrectomy (and metastasectomy in M1 no evidence of disease patients) with negative surgical margins, and (vi) ECOG performance status 0-1. The goal is to accrue 950 patients who will then be randomly assigned 1:1 to receive pembrolizumab 200 mg every 3 weeks by intravenous infusion, or placebo, continued for up to 17 cycles (∼1 year) or until disease recurrence or treatment discontinuation. Randomization will be stratified by metastasis stage (M0 vs M1 no evidence of disease). Within the M0 group, randomization will be further stratified by ECOG performance status (0 vs 1) and region (US vs rest of world). The primary end point is investigator-assessed disease-free survival (DFS) and radiographic imaging will be performed every 12 weeks. Secondary objectives include (i) overall survival (OS), (ii) safety, (iii) disease recurrence-specific survival, (iv) DFS and OS according to PD-L1 expression status, (v) pharmacokinetics, (vi) antidrug antibodies, and (vii) patient-reported outcomes. Molecular biomarkers that may be associated with response, safety, pharmacodynamic activity, or mechanism of action will be evaluated as exploratory objectives. Recruitment is ongoing and will continue until ~950 patients are enrolled.
Speaker: Tian Zhang, Macquarie University Hospital, NSW, Australia
Co-Authors: Howard Gurney, Gurjyot Doshi, Patrick Cobb, Francis Parnis, Jae Lyun Lee, Se Hoon Park, Andrey Semenov, Yen Hwa Chang, Thomas Powles, David I. Quinn, Shuyan Wan, Christian Poehlein, Toni K. Choueiri
Written by: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, @zklaassen_md, at the 18th Annual Meeting of the Society of Urologic Oncology, November 29-December 1, 2017 – Washington, DC
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