Assessments
tumor, Cancer
ADVERSE EVENTS, TUMOR, DISEASE, CANCER
Safety was monitored regularly from the signing of the informed consent form until 30 days post end of treatment (and then at 12 weeks post end of treatment) by physical examination, electrocardiogram, assessment of blood hematology, clinical chemistry, urinalysis, vital signs, and assessment of adverse events (AEs)/serious AEs (SAEs), which were graded according to National Cancer Institute Common Terminology Criteria for AEs version 4.03. Disease assessments per RECIST v1.1 [Oleclumab and durvalumab serum concentrations were measured using a validated colorimetric enzyme-linked immunosorbent assay (ELISA) with a lower limit of quantitation of 1.00 µg/mL for oleclumab and 0.05 µg/mL for durvalumab. Pharmacokinetic parameters were estimated by noncompartmental analysis using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA). ADA responses to oleclumab and durvalumab were evaluated using a validated electrochemiluminescent immunoassay.Flow cytometry for evaluation of total numbers and subsets of T cells was performed by Covance Central Lab Services/Lab Corp using analytically validated assays (Supplementary Methods). The concentration of soluble CD73 in human serum samples was determined using an ELISA, and whole blood samples were analyzed for circulating levels of soluble factors (Supplementary Methods). Immunohistochemistry was used to analyze matched pairs of tumor specimens at screening and during therapy (Supplementary Methods). A CD73 enzymatic assay was conducted on matched pairs of tumor specimens (Supplementary Methods).