Assessment of Drug-Drug Interactions Between Immune Checkpoint Inhibitors and Cytochrome P450 Substrates: Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study
Indiana University
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.
Description
Findings suggest that adverse events during checkpoint inhibitor therapy may, in part, be caused by drug-drug interactions that increase the risk of adverse events with co-administered medications. Identifying these novel drug-drug interactions will likely inform clinical strategies to reduce adverse events during checkpoint inhibitor therapy and enhance their clinical benefits. This current research aims to systematically explore the impact of ICIs on CYP/transporter function and the associated risks for adverse events, thereby informing clinical strategies to mitigate these risks and optimi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 nor…
Interventions
- DrugICI Therapy
Low dose of a cocktail of probe substrates for eight major CYP enzymes/drug transporters.
Location
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana