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This drug is a **triple combination regimen** consisting of three distinct agents: - **Ivosidenib** is a small molecule inhibitor specifically targeting the mutant isocitrate dehydrogenase 1 (IDH1) enzyme, which is mutated in some cancers such as cholangiocarcinoma. - **Nivolumab** is a monoclonal antibody acting as an immune checkpoint inhibitor that blocks the programmed death-1 (PD-1) receptor on T cells, enhancing anti-tumor immune responses. - **Ipilimumab** is a monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), another checkpoint inhibitor, further stimulating T-cell-mediated anti-tumor activity. Taken together, this combination aims to both directly inhibit oncogenic metabolic pathways (via ivosidenib) and synergistically boost anti-tumor immunity (via dual checkpoint blockade with nivolumab and ipilimumab). Its primary development focus is for **unresectable or metastatic cholangiocarcinoma with an IDH1 mutation**, especially in patients who have progressed on standard therapies. Development is in clinical trials (Phase 1/2) to evaluate safety, recommended combination dosing, and preliminary efficacy[2][3][4][5]. The study is sponsored by Institut de Recherches Internationales Servier.
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