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J Clin Oncol. 2017 Dec 1;35(34):3851-3858. doi: 10.1200/JCO.2016.72.1985. Epub 2017 Jul 5.

Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study.

Author information

1
Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Jeffrey R. Infante, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Lionel D. Lewis, The Geisel School of Medicine and The Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, NH; Martin H. Voss, Memorial Sloan Kettering Cancer Center, New York, NY; Padmanee Sharma, MD Anderson Cancer Center, University of Texas, Houston, TX; Sumanta K. Pal, City of Hope Comprehensive Cancer Center, Duarte, CA; Albiruni R. Abdul Razak, Princess Margaret Cancer Centre, Toronto, Ontario; Christian Kollmannsberger, British Columbia Cancer Agency, Vancouver, British Columbia; Daniel Y.C. Heng, Tom Baker Cancer Center, University of Calgary, Calgary; Jennifer Spratlin, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; M. Brent McHenry, Bristol-Myers Squibb, Princeton, NJ; and Asim Amin, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC.

Abstract

Purpose Combination treatment with immune checkpoint inhibitors has shown enhanced antitumor activity compared with monotherapy in tumor types such as melanoma. The open-label, parallel-cohort, dose-escalation, phase I CheckMate 016 study evaluated the efficacy and safety of nivolumab plus ipilimumab in combination, and nivolumab plus a tyrosine kinase inhibitor in metastatic renal cell carcinoma (mRCC). Safety and efficacy results from the nivolumab plus ipilimumab arms of the study are presented. Patients and Methods Patients with mRCC received intravenous nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (N3I1), nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (N1I3), or nivolumab 3 mg/kg plus ipilimumab 3 mg/kg (N3I3) every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks until progression or toxicity. End points included safety (primary), objective response rate, and overall survival (OS). Results All patients in the N3I3 arm (n = 6) were censored at the time of analysis as a result of dose-limiting toxicity or other reasons. Forty-seven patients were treated in both the N3I1 and the N1I3 arm, and baseline patient characteristics were balanced between arms. Grade 3 to 4 treatment-related adverse events were reported in 38.3% and 61.7% of the patients in the N3I1 and N1I3 arms, respectively. At a median follow-up of 22.3 months, the confirmed objective response rate was 40.4% in both arms, with ongoing responses in 42.1% and 36.8% of patients in the N3I1 and N1I3 arms, respectively. The 2-year OS was 67.3% and 69.6% in the N3I1 and N1I3 arms, respectively. Conclusion Nivolumab plus ipilimumab therapy demonstrated manageable safety, notable antitumor activity, and durable responses with promising OS in patients with mRCC.

PMID:
28678668
DOI:
10.1200/JCO.2016.72.1985
[Indexed for MEDLINE]

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