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sotigalimab + nivolumab + ipilimumab is an investigational combination immunotherapy regimen being evaluated for the treatment of advanced cancers. The regimen consists of sotigalimab (APX005M), a humanized monoclonal antibody that acts as an agonist for the CD40 receptor to activate antigen-presenting cells; nivolumab (Opdivo), a monoclonal antibody that inhibits the PD-1 checkpoint; and ipilimumab (Yervoy), a monoclonal antibody that inhibits the CTLA-4 checkpoint. By combining a CD40 agonist with dual checkpoint blockade, the regimen is designed to simultaneously stimulate the innate immune system and remove inhibitory signals on T-cells, potentially overcoming resistance to standard immunotherapy. This specific triplet combination has been studied in Phase 1 investigator-initiated trials led by Yale University for treatment-naive patients with advanced melanoma or renal cell carcinoma (RCC).
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