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

NCT07389525 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

ICI Therapy

Low dose of a cocktail of probe substrates for eight major CYP enzymes/drug transporters.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Tyler Shugg, MD · IUSCCC

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389525 on ClinicalTrials.gov