Study Endpoints and Assessments
tumor
ADVERSE EVENT, TUMOR, DISEASE, EVENT, ADVERSE EVENT
The primary study endpoint was safety and tolerability in Part 1, assessed by monitoring the frequency, duration, and severity of AEs. A treatment-emergent adverse event (TEAE) was defined as an AE either reported for the first time or worsening of a preexisting event after first dose of study drug. AEs were classified into system organ class and Medical Dictionary for Regulatory Activities preferred term, and severity of AEs was assessed using Common Terminology Criteria for Adverse Events (v4.03). Secondary endpoints in Part 1 and 2 were ORR determined by radiographic disease assessments per RECIST v1.1, and change in the number of tumor-infiltrating lymphocytes (TIL) and ratio of CD8Exploratory study endpoints in Part 1 and 2 were pharmacokinetics of itacitinib and parsaclisib, and biomarker effects in plasma and tumor tissue after treatment with itacitinib or parsaclisib in combination with pembrolizumab. Plasma samples for pharmacokinetic analysis were collected predose on cycle 1 day 1, day 8 (±3 days), day 15 (±3 days), and cycle 2 day 1 (±3 days). On day 1 of cycle 1 and 2, plasma samples were also collected at 60 (±10) minutes, 2 (±0.5) hours, 4 (±0.5) hours, and 6 (±1) hours postdose. Plasma concentrations of itacitinib or parsaclisib were determined using validated LC/MS-MS method (Incyte Research Corporation; refs. 