placebo + nivolumab

placebo + nivolumab is a combination regimen used as the active control arm in clinical trials, most notably in the Phase 3 study (NCT04674683) sponsored by HUYABIO International for the treatment of unresectable or metastatic melanoma. This regimen consists of nivolumab (Opdivo), a human programmed death receptor-1 (PD-1) blocking monoclonal antibody, administered intravenously, and an oral placebo tablet. Nivolumab functions as a checkpoint inhibitor by binding to the PD-1 receptor on T cells and preventing its interaction with the ligands PD-L1 and PD-L2. This blockade alleviates the immunosuppressive signals in the tumor microenvironment, thereby enhancing T-cell activation and proliferation to mount an effective anti-tumor immune response. The placebo component is used to maintain the double-blind nature of the trial when compared against the experimental arm containing the HDAC inhibitor HBI-8000.

Brand names

Opdivo

Other names

placebo plus nivolumab