Ipilimumab And Gemcitabine For Advanced Pancreas Cancer: A Phase Ib Study.

e15747Background: Resistance of pancreatic adenocarcinoma (PDA) to therapy remains a challenge. One factor of the barrier is the T-lymphocyte driven inflammatory response seen in PDA. The CTLA-4 T-cell receptor provides inhibitory signals to the T cells that serve to dampen antitumor immune responses. Abrogating CTLA-4 represents a novel strategy to induce tumor regression, stabilize disease, and prolong survival by manipulating the immune system. Blocking CTLA-4 may sustain activation and proliferation of tumor specific T-cells, or alter the phenotype of tumor specific Treg . Ipilimumab (IPI), a monoclonal antibody to the CTLA-4 receptor, downregulates T-cell responses. Objective: Determine MTD of IPI combined with gemcitabine (GEM) for PDA. Methods: Single institution study with dose escalation performed in a 3+3 fashion. Dose expansion was performed at the MTD. Therapy consisted of 12 weeks of induction with DLT determined after week 12. Maintenance therapy to continue indefinitely if clinical benefit ...