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This combination therapy consists of a p53 peptide vaccine (specifically the wild-type p53 264-272 peptide) and pidilizumab (CT-011), an anti-PD-1 monoclonal antibody. The p53 vaccine is an investigational immunotherapy designed to stimulate the immune system to recognize and destroy cancer cells that overexpress or harbor mutations in the p53 protein, a common driver in various malignancies. Pidilizumab acts as a checkpoint inhibitor, blocking the Programmed cell death protein 1 (PD-1) pathway to enhance and sustain the T-cell mediated immune response initiated by the vaccine. This combination was primarily evaluated by the National Cancer Institute (NCI) in a Phase I dose-escalation trial for HLA-A2 positive patients with advanced solid tumors, including breast cancer, colon cancer, pancreatic cancer, sarcoma, and ovarian cancer, whose tumors overexpress the p53 protein.
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