Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study

This study is looking into how immune checkpoint inhibitors (ICIs), also called immunotherapy, might affect how your body processes other medicines. Sometimes, ICIs can cause serious side effects, and this study wants to see if those side effects happen because ICIs change how your liver handles other drugs you might be taking. To understand this, participants will receive a low dose of a mix of 7 FDA-approved drugs (a "probe cocktail") that are processed in different ways by the liver. The study will measure how these drugs are handled in your body from before you start ICI therapy up to 84 days later. This research aims to find ways to reduce side effects and improve the benefits of ICI therapy. You can join if you are 18 or older, have cancer, and are starting treatment with an immune checkpoint inhibitor like atezolizumab, cemiplimab, durvalumab, ipilimumum, nivolumab, pembrolizumab, relatlimab, or tremelimumab. The current status of this study is unclear.

Study design: This is an interventional study with a planned enrollment of 80 participants. It uses a rigorous crossover drug-drug interaction design.
What's involved: You would receive ICI therapy and a low dose of a cocktail of probe substrates. Plasma concentrations will be measured at baseline (before ICI therapy) and up to day 84.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for changes in plasma concentrations and toxicity concentrations from baseline up to day 84.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study

Not Yet Recruiting

EARLY_PHASE1Ages 18+InterventionalBasic science

Indiana University

~80 participants

Updated 2026-07-15 on ClinicalTrials.gov

What's tested:ICI Therapy

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in plasma concentrations from drug exposure during ICI therapy

Measured over baseline (before start of ICI therapy) up to day 84

+2 more outcomes measured

Conditions

Gastrointestinal Neoplasms

Genitourinary Cancer

Thoracic Cancer

Sarcoma

Melanoma

Where it's being run

1 sites across 1 states

Indiana1

Study leadership

Tyler Shugg, MD · PRINCIPAL_INVESTIGATOR · IUSCCC

Who to contact

Ross Robinson

[email protected]

317-381-1426

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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

Exclusion

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)

Past medical history of chronic liver disease, signs and symptom of liver disease (e.g., jaundice, ascites), or aspartate aminotransferase \>96 U/L, alanine aminotransferase \> 80 IU/L, alkaline phosphatase \>260 U/L, or total bilirubin \> 2.6 mg/dL

Note: if a prospective patient's liver function tests return to the normal ranges, they can be re-screened for trial inclusion)

Past medical history of chronic kidney disease, signs and symptom of kidney disease (e.g., decreased urine output, swelling in feet and ankles), or estimated glomerular filtration rate \<45 mL/minute/1.73 m2 BSA

Note: if a prospective patient's kidney function returns to the normal range, they can be re-screened for trial inclusion)

Poor performance status that makes it unlikely the patient will complete 3 cycles of immune checkpoint inhibitor (at the treating oncologist's discretion)

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

History of intolerance, allergic reaction, or hypersensitivity to any of the study drugs (tizanidine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, rosuvastatin)

Current infection requiring medical treatment (note: if a prospective patient's infection resolves, they can be re-screened for trial inclusion)

Concomitant treatment with systemic immunosuppressant drugs (see Appendix 3 for list)

Note: patients may be re-screened for trial eligibility if they discontinue any exclusionary drugs for ≥7 days prior to Study Visit 1

Concomitant treatment with a CYP/transporter probe cocktail drug or strong inhibitors, inducers, or agents that affect the pharmacokinetics of the relevant CYP enzymes or drug transporters (see Appendix 4 for list)

Note: patients may be re-screened for trial eligibility if they discontinue any exclusionary drugs for ≥7 days prior to Study Visit 1

Are unwilling/unable to avoid drugs of abuse, tobacco products or marijuana, or consuming more than 2 alcoholic drinks per day during the study

Inability to take oral medication

What this trial measures

Change in plasma concentrations from drug exposure during ICI therapybaseline (before start of ICI therapy) up to day 84
Toxicity concentrations for CYP/transporter substrate drugs in plasmabaseline (day before Cycle 1 start) up to day 84
Associations between pro-inflammatory cytokine concentrations and CYP/transporter probe drug concentrations in plasmabaseline (day before Cycle 1 start) up to day 84

Trialytics