PRIMARY OBJECTIVE:
I. To perform a steady-state PK study on patients who are taking monoclonal antibody therapy (25 patients starting pembrolizumab and 25 patients starting nivolumab for melanoma or non-small cell lung cancer).
II. Develop and validate a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay to measure pembrolizumab and nivolumab in serum.
III. Measure patient samples for pembrolizumab/nivolumab at various clinical time points.
IV. Use the pharmacokinetic data (drug concentrations) to determine the area under the curve (AUC), maximum observed serum concentration (Cmax), clearance, half-life (t1/2), and trough steady-state drug concentrations.
V. Compare the data to the clinical efficacy (defined using Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria)1, as well as, presence of auto-immune side effects using multiple variable regression modeling in Statistical Analysis System (SAS) version (v)9.4 or other statistical software.
OUTLINE:
Patients undergo collection of blood samples and have medical records reviewed on study.
