NCT05707286|CompletedDMC
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
ICI-PICK
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ICI-PICK
Sponsor study identifier
Secondary identifiers
NIH
observational
98
1 country
1
Study Start
September 7, 2023
Actual (reported)Primary Completion
January 20, 2025
Actual (reported)Study Completion
January 20, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 20, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2023
Actual (reported)January 31, 2023
Actual (reported)September 7, 2023
Actual (reported)January 20, 2025
Actual (reported)January 20, 2025
Actual (reported)Increases in pro-inflammatory cytokines
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.
From baseline (day -30) up to cycle 4 (day 126)
Populations of activated T cells
From baseline (day -30) up to cycle 4 (day 126)
Increases in other cytokines
From baseline (day -30) up to cycle 4 (day 126)
Adults diagnosed with solid cancers and initiating therapy with an immune checkpoint inhibitor
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
This study is observational in nature and will involve no medical interventions outside of collecting 5-7 blood samples at 5-7 separate study visits.
Tyler Shugg, PharmD, PhD
Indiana University
98 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2023
First Posted
January 31, 2023
Study Start
September 7, 2023
Actual (reported)Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
Plasma concentrations of immune checkpoint inhibitors
From baseline (day -30) up to cycle 4 (day 126)
Plasma concentrations of co-administered CYP substrate medications
From baseline (day -30) up to cycle 4 (day 126)
The development of immune-related adverse events
From baseline (day -30) up to cycle 4 (day 126)
The development of adverse drug events attributable to co-administered CYP substrate medications
From baseline (day -30) up to cycle 4 (day 126)
Contact the study team to confirm eligibility.
Primary Completion
January 20, 2025
Actual (reported)Study Completion
January 20, 2025
Actual (reported)Last Updated
January 7, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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