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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07389525
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Neoplasms
  • Genitourinary Cancer
  • Melanoma
  • Sarcoma
  • Thoracic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ICI Therapy — DRUG
    Low dose of a cocktail of probe substrates for eight major CYP enzymes/drug transporters.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1
    CYP enzyme/drug transporter probe substrates administered at two study visits: one before initiation of ICI therapy and one while on therapy.
  • Experimental: Cohort 2
    CYP enzyme/drug transporter probe substrates administered at one study visit: during ICI therapy.

Primary Outcome Measure

Change in plasma concentrations from drug exposure during ICI therapy [ Time Frame: baseline (before start of ICI therapy) up to day 84 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Ross Robinson
[email protected]
317-381-1426
Tyler Shugg, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN

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