1. Yamamoto N, Nokihara H, Yamada Y, et al., Phase I study of Nivolumab, an anti-PD-1 antibody, in patients with malignant solid tumors, Invest New Drugs,DOI 10.1007/s10637-016-0411-2.
2. Bajaj G, Wang X, Agrawal S, Gupta M, Roy A and Feng Y, Model-Based Population Pharmacokinetic Analysis of Nivolumab in Patients With Solid Tumors, CPT Pharmacometrics Syst. Pharmacol. 2016; 00, 00; doi:10.1002/psp4.12143; published online on 0 Month 2016.
3. Agrawal S, Statkevich P, Bajaj G, Feng Y, Saeger S,et al., Evaluation of Immunogenicity of Nivolumab Monotherapy and Its Clinical Relevance in Patients With Metastatic Solid Tumors, The Journal of Clinical Pharmacology, 2016; 00(0) 1–7. DOI: 10.1002/jcph.818
4. Wang C, Thudium K.B, Han M, et al, In Vitro Characterization of the Anti-PD-1 Antibody Nivolumab, BMS-936558, andIn Vivo Toxicology in Non-Human Primates, Cancer Immunol Res, 2014; 2(9); 846–56.
5. Agrawal S, Waxman I, Lambert A, Roy A, Darbenzio R, Evaluation of the potential for QTc prolongation in patients with solid tumors receiving nivolumab, Cancer Chemother Pharmacol, 2016; 77: 635–641.
6. Li Y, Fu T, Liu T, Guo H et al. Characterization of alanine to valine sequence variants in the Fc region of nivolumab biosimilar produced in Chinese hamster ovary cells, mAbs, 2016; 8:5, 951-960, DOI: 10.1080/19420862.2016.1172150
7. Brahmer JR, Drake CG, Wollner I, Powderly JD, Phase I Study of Single-Agent Anti–Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates, J Clin Oncol, 2010; 28: 3167-75
8. Wolchok JD, Kluger H, Callahan MK, Postow MA, et al. Nivolumab plus Ipilimumab in Advanced Melanoma, N Engl J Med 2013;369:122-33.
9. Scott LJ, Nivolumab: A Review in Advanced Melanoma, Drugs, 2015; 75: 1413–1424.
10. Kanda S, Goto K, Shiraishi H, Kubo E, Tanaka A, Utsumi H, Sunami K, Kitazono S, Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study, Annals of Oncology, 2016; 27: 2242–50.
11. Kimura T, Fukushima S, Miyashita A, Aoi J, Jinnin M, Kosaka T,et al. Myasthenic crisis and polymyositis induced by one dose of nivolumab, Cancer Sci, 2016; 107: 1055–58.
12. Nakamura Y, Kitano S, Takahashi A, Tsutsumida A,et al. Nivolumab for advanced melanoma: pretreatment prognostic factors and early outcome markers during therap, Oncotarget, 2016; 7(47): 77404-77415.
13. Keating GM, Nivolumab: A Review in Advanced Squamous Non-Small Cell Lung Cancer, Drugs, 2015; 75: 1925–34.
14. Zhou GW, Xiong Y, Chen S, Xia F, Li Q, Hu J, Anti-PD-1/PD-L1 antibody therapy for pretreated advanced nonsmall-cell lung cancer: A meta-analysis of randomized clinical trials, Medicine, 2016; 95: 35.
15. Jung K, Zeng X, Bilusic M, Nivolumab-associated acute glomerulonephritis: a case report and literature review, BMC Nephrology 2016; 17: 188.