Clinical trial · Observational
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
NCT05707286CI-TRIAL-00100289ICI-PICKcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Genitourinary Cancer | Malignant Genitourinary System Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Increases in pro-inflammatory cytokines
- timeFrame
- From baseline (day -30) up to cycle 4 (day 126)
- description
- Determine the time course of increases in pro-inflammatory cytokines during treatment with immune checkpoint inhibitor regimens, via plasma cytokine concentrations present in blood samples.
- measure
- Populations of activated T cells
- timeFrame
- From baseline (day -30) up to cycle 4 (day 126)
Secondary outcomes (6)
- measure
- Increases in other cytokines
- timeFrame
- From baseline (day -30) up to cycle 4 (day 126)
- description
- Determine the time course of increases in other cytokines during treatment with immune checkpoint inhibitor regimens, including anti-inflammatory cytokines (e.g., IL-10, TGF-β) present in blood samples.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. 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) 3. Ability to provide written informed consent and HIPAA authorization Exclusion Criteria: 1. 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 2. Current infection requiring medical treatment (note: if a prospective subject's infection resolves, they can be re-screened for trial inclusion) 3. Concomitant treatment with systemic immunosuppressant drugs (see Table A1 in appendix for complete list)
References
Publications (0)
Data not yet available
No reference posted for this study.