From prior experience, ADI-PEG 20 exhibited acceptable safety profiles when administered at the recommended dose of 36 mg/m2 in combination with specific chemotherapy regimens.7–9 The safety of ADI-PEG 20, however, has not been documented with ICTs. Thus, we conducted an open-label, single-center, phase 1b trial of ADI-PEG 20 plus pembrolizumab with the primary objective to assess safety and tolerability of the combination (ClinicalTrials.gov: NCT03254732). The secondary objectives were to assess the maximum tolerated dose (MTD) for a recommended phase 2 dose, progression-free survival (PFS), overall survival (OS), overall response rate (ORR) by RECIST 1.1 and by Immune-Related Response Criteria (irRC),18 and the effect of ADI-PEG 20 on the expression of PD-L1 and T-cell infiltration.

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