Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy

This research aims to identify clinical strategies to manage adverse events during immune checkpoint inhibitor therapy by (1) determining the impact of checkpoint inhibitors on metabolism through major CYP enzymes and (2) identifying associations between pro-inflammatory cytokine concentrations and negative clinical outcomes during checkpoint inhibitor therapy.

Inclusion Criteria:≥ 18 years old at the time of informed consentDiagnosed with non-small cell lung cancer (NSCLC) OR melanoma AND initiating therapy with single agent or combination therapy that includes an immune checkpoint inhibitor, (e.g., atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab)Ability to provide written informed consent and HIPAA authorizationExclusion Criteria:Diagnosis or past medical history of autoimmune disorder, including rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitisCurrent infection requiring medical treatment (note: if a prospective subject's infection resolves, they can be re-screened for trial inclusion)Concomitant treatment with systemic immunosuppressant drugs (see Table A1 in appendix for complete list)