NCT05707286Completed
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 98 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 7 Sept 2023
- Primary completion date
- 20 Jan 2025
- Lead sponsor
- Indiana University
- NCT number
- NCT05707286
What you commit to
- Study type: Observational
- Participants enrolled: 98
- From 7 Sept 2023 to the primary completion date, 20 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with systemic immunosuppressant drugs (see Table A1 in appendix for complete list)
Other illness
- 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)
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.