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ipilimumab + sipuleucel-T is a combination immunotherapy regimen investigated for the treatment of chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). This therapeutic approach combines ipilimumab, a fully human monoclonal antibody that inhibits the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) immune checkpoint, with sipuleucel-T, an autologous cellular immunotherapy. Sipuleucel-T is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, by using patient-derived peripheral blood mononuclear cells activated ex vivo with a recombinant fusion protein (PA2024). The rationale for the combination is that CTLA-4 blockade by ipilimumab can augment the T-cell response primed by sipuleucel-T. A Phase 2 randomized trial (NCT01804465) conducted by the University of California, San Francisco (UCSF) and MD Anderson Cancer Center evaluated the efficacy and timing of this combination, comparing immediate versus delayed ipilimumab administration following sipuleucel-T treatment.
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