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A Phase 1b Trial of the IRX-2 Regimen and Durvalumab (MEDI4736), in Patients with Incurable Head and Neck Squamous Cell Carcinoma
The purpose of this study is to see if the IRX-2 regimen and Durvalumab will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.
Primary Objectives: To determine the safety profile of a combination of the IRX-2 regimen, durvalumab and tremelimumab (IDT). To evaluate the biological effects of IDT determined by changes in the expression of PD-L1 in the tumor cells and immune cells in tumor microenvironment. To evaluate the biological effects of IDT determined by changes in the density of lymphocyte infiltration in the tumor and tumor microenvironment. Secondary Objective(s): To evaluate the objective clinical response rate of IDT. To evaluate the progression-free survival of IDT at 6 months.