作者
Asim Amin, Elizabeth R Plimack, Jeffrey R Infante, Marc S Ernstoff, Brian I Rini, David F McDermott, Jennifer J Knox, Sumanta Kumar Pal, Martin Henner Voss, Padmanee Sharma, Christian K Kollmannsberger, Daniel Yick Chin Heng, Jennifer L Spratlin, Yun Shen, John F Kurland, Paul Gagnier, Hans J Hammers
发表日期
2014/5/20
来源
Journal of Clinical Oncology
卷号
32
期号
15_suppl
页码范围
5010-5010
出版商
American Society of Clinical Oncology
简介
5010
Background: Antiangiogenic agents sunitinib (S) and pazopanib (P) are SOC for mRCC, but new therapies are needed as pts advance through therapy with limited survival benefit. We report preliminary results of a phase I trial of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, in combination with S or P in pts with mRCC. Methods: mRCC patients (≥1 prior systemic therapy) received nivolumab in combination with S (50 mg, 4 wks on, 2 wks off; arm S) or P (800 mg daily; arm P), until progression/unacceptable toxicity. Starting dose of nivolumab was 2 mg/kg IV Q3W (N2), with planned escalation to 5mg/kg IV Q3W (N5). Based on tolerability, arm S N5 cohort was expanded to treatment-naïve pts. Primary objectives were safety/tolerability and determination of maximum tolerated dose (MTD) for the combinations; secondary objective was antitumor activity (objective response rate …
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