Phase 2 Trial Of The Ido Pathway Inhibitor Indoximod Plus Checkpoint Inhibition For The Treatment Of Patients With Advanced Melanoma

9512Background: The indoleamine 2,3-dioxygenase (IDO) pathway is a key counter-regulatory mechanism that, in cancer, is exploited by tumors to prevent and evade anti-tumor immunity. Inhibitors of the IDO pathway, such as indoximod, are an increasingly validated class of potential cancer therapeutics. Pre-clinical data and an increasing body of clinical data support evaluating the combination of a checkpoint inhibitor (CI) with an IDO pathway inhibitor as potential treatment for advanced melanoma. Methods: Advanced melanoma patients were enrolled in a single arm Phase 2 trial evaluating the addition of indoximod to standard of care CI as approved for melanoma. Prior therapy excluding CI was allowed. Investigators administered their choice of approved CI (pembrolizumab (P), nivolumab (N), ipilimumab (I). Indoximod was administered continuously (1200mg po BID), concurrent CI dosed per approved US label. Study endpoint was best overall response (overall response rate (ORR) = complete response (CR) + partial r...