Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
Immune checkpoint inhibitors (ICIs) (also called "immunotherapy") are an effective family of anti-cancer drugs, but they can cause serious side effects. Some evidence suggests these side effects might happen because ICIs interact with other drugs that you may already be taking, making those drugs work differently, or causing more side effects. The purpose of this study is to see whether ICIs impact how the liver processes other drugs. To do this, participants will be given a probe cocktail of 7 different FDA-approved drugs that are processed in different ways in the liver.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old at the time of informed consent
Diagnosed with cancer AND initiating therapy with single agent or combination therapy that includes an immune checkpoint inhibitor (e.g., atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, relatlimab, tremelimumab)
Ability to provide written informed consent and HIPAA authorization
Disqualifiers
Actively pregnant or breastfeeding
Body weight less than 50 kg or a BMI >35
Low baseline hemoglobin, defined as <10 g/dL
Note: if a prospective patient's hemoglobin returns to the normal range, they can be re-screened for trial inclusion)
Trial design
Design model
Crossover
Treatments tested in this trial
ICI Therapy
DrugLow dose of a cocktail of probe substrates for eight major CYP enzymes/drug transporters.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in plasma concentrations from drug exposure during ICI therapy
Time frame
baseline (before start of ICI therapy) up to day 842
Toxicity concentrations for CYP/transporter substrate drugs in plasma
Time frame
baseline (day before Cycle 1 start) up to day 843
Associations between pro-inflammatory cytokine concentrations and CYP/transporter probe drug concentrations in plasma
Time frame
baseline (day before Cycle 1 start) up to day 84Secondary outcomes
1
Assess associations between T cells populations and CYP/transporter probe drug concentrations
Peripheral blood mononuclear cells (PBMCs)
Time frame
baseline (day before Cycle 1 start) up to day 842
Concentrations of endogenous biomarkers
Plasma or urine
Time frame
baseline (day before Cycle 1 start) up to day 843
CYP/transporter endogenous biomarker concentrations
Plasma or urine correlated with plasma concentrations of pro-inflammatory cytokines
Time frame
baseline (day before Cycle 1 start) up to day 844
Correlation of concentration of population of activated T cells and CYP/transporter endogenous biomarkers
Plasma or urine
Time frame
baseline (day before Cycle 1 start) up to day 84Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: