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This combination therapy is an experimental immunotherapeutic regimen being evaluated in a Phase 2 clinical trial (NCT04134559) led by Georgetown University. It consists of three distinct components: nivolumab, a monoclonal antibody that inhibits the programmed death-1 (PD-1) receptor to enhance T-cell mediated anti-tumor activity; daratumumab, a monoclonal antibody targeting CD38, which is utilized in this context to deplete immunosuppressive myeloid-derived suppressor cells (MDSCs) and regulatory T cells (Tregs) within the tumor microenvironment; and TG01, a peptide-based vaccine designed to stimulate a specific T-cell response against mutant KRAS proteins. The regimen is specifically targeted at patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC) who harbor KRAS mutations, aiming to leverage the synergy between checkpoint inhibition, myeloid cell modulation, and antigen-specific vaccination to overcome tumor-induced immunosuppression.
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