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

Starting soon · Early Phase 1

Conditions studied: Gastrointestinal Neoplasms, Genitourinary Cancer, Thoracic Cancer, Sarcoma, Melanoma

In brief

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.

Key facts

Study ID

NCT07389525

Run by

Indiana University

People needed

80

Starts

2026-09-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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