PHARMACEUTICAL INFORMATION A list of the adverse events and potential risks associated with the investigational agent administered in this study can be found in Section 7.1. 9.1 Nivolumab 9.1.1 Description Nivolumab is a fully human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the PD-1 cell surface membrane receptor. Nivolumab inhibits the interaction of PD-1 with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation and interferon- gamma (IFN-γ) release in vitro. 9.1.2 Form Nivolumab Injection, 100 mg/10 mL (10 mg/mL) is a clear to opalescent, colorless to pale yellow liquid, which may contain light (few) particulates. The drug product is a sterile, nonpyrogenic, single-use, isotonic DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 26 aqueous solution formulated at 10 mg/mL in sodium citrate, sodium chloride, mannitol, diethylenetriaminepentacetic acid (pentetic acid), and polysorbate 80, pH 6.0 and includes a 0.7 mL overfill to account for vial, needle, and syringe (VNS) holdup. It is supplied in 10-cc Type I flint glass vials, stoppered with butyl rubber stoppers and sealed with aluminum seals.