Immunotherapy may change how your body processes other drugs
NCT ID NCT07389525
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study will test whether immunotherapy drugs (immune checkpoint inhibitors) change how the liver processes other medications. About 80 adults with various cancers who are starting immunotherapy will take a low-dose cocktail of 7 common drugs. Researchers will measure drug levels in the blood to see if interactions occur, which could explain some side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- immune checkpoint inhibitors (immunotherapy) and a cocktail of 7 FDA-approved drugs
- What this could lead to
- If successful, this could help doctors predict and prevent dangerous drug interactions in cancer patients on immunotherapy.
- What could go wrong
- This is a very early, small study (80 people) that only measures drug levels, not treatment outcomes. Results may not apply to all patients or drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥ 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A prospective imaging study of target definition and radiation planning workflows on the integrated TrueBeam-HyperSight system for patients receiving radiation therapy
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?