CompletedNot Applicable

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

United States98 participantsStarted 2023-09-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ≥ 18 years old at the time of informed consent
✓. Diagnosed 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 authorization

Exclusion criteria

✕. Diagnosis or past medical history of autoimmune disorder, including systemic lupus erythematosus, Crohn's disease, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis
✕. Current 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)

What they're measuring

Increases in pro-inflammatory cytokines

Timeframe: From baseline (day -30) up to cycle 4 (day 126)

Populations of activated T cells

Timeframe: From baseline (day -30) up to cycle 4 (day 126)

Trial details

NCT IDNCT05707286

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-20

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