For this study, key eligibility criteria included (i) age ≥18 years, (ii) histologically confirmed mRCC with clear cell component (with or without sarcomatoid features), (iii) measurable disease (RECIST v1.1), (iv) no prior systemic therapy for advanced disease, (v) Karnofsky performance status ≥70%, and (vi) provision of a tumor sample for biomarker analyses. Patients will be stratified by IMDC risk category and geographic region, and approximately 840 patients will be randomly assigned 1:1 to receive pembrolizumab 200 mg every 3 weeks + axitinib 5 mg twice daily or sunitinib 50 mg once daily for 4 weeks followed by 2 weeks off. Treatment will continue until progressive disease, unacceptable adverse events, or withdrawal of consent. Notably, patients in the pembrolizumab arm may receive up to 35 doses of medication, after which axitinib-only treatment may continue. Primary end points are to compare progression-free survival (RECIST v1.1) and overall survival between treatment arms. Secondary end points include the (i) ORR, (ii) duration of response, (iii) disease control rate, safety, and (iv) patient-reported outcomes between arms. Abdominal imaging will be performed at week 12, then every 6 weeks for the first year, and every 12 weeks thereafter. Bone scans will be performed at baseline, and if positive, repeated at week 18, 30, 42, and 54, and every 24 weeks thereafter. This study has started enrolling patients in 16 countries worldwide and is currently ongoing.
Clinical trial: NCT02853331
Presented By: Brian I. Rini, Cleveland Clinic, Cleveland, OH, USA
Co-Authors: Thomas Powles, Mei Chen, Markus Puhlmann, Michael B. Atkins
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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