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Clinical Trial Summary

This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and pembrolizumab treatment.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03200847
Study type Interventional
Source University of Colorado, Denver
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date October 31, 2017
Completion date August 2024

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