Stage IV Melanoma Clinical Trial
Official title:
Pembrolizumab and All-Trans Retinoic Acid in Combination Treatment of Advanced Melanoma
This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and pembrolizumab treatment.
Primary Objective - To identify the MTD and RP2D of the combination of pembrolizumab and ATRA. Secondary Objective: - Describe the safety and toxicity of combined treatment with pembrolizumab and all-trans retinoic acid (ATRA) [brand name VESANOID] in melanoma patients. - To assess the anti-tumor activity in terms of a). The reduction in MDSC (immunosuppressive myeloid -derived suppressor cells) frequency and suppressive function (measured as a continuous variable)in peripheral blood of advanced melanoma patients undergoing pembrolizumab and VESANOID combination therapy. b). progression free survival. Exploratory Objective - To determine the clinical outcomes with tumor-specific T cell responses. ;
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