Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
Qualifiers
≥ 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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- ICI Therapy
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov