Separating heart side effects from cancer benefit of immunotherapy

Metabolomic and Genetic Factors Decoupling Immune Checkpoint Inhibitor Tumor Efficacy and Cardiovascular Toxicity

This project will try to find which adults starting immune checkpoint inhibitors are likely to have heart problems versus cancer benefit by testing blood markers like metabolomics, CHIP, and epigenetic aging.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07382752 on ClinicalTrials.gov

What this trial studies

This observational study will enroll adults starting immune checkpoint inhibitor (ICI) therapy and collect baseline blood samples prior to treatment. Researchers will analyze metabolomic signatures from human monocyte-derived macrophages, clonal hematopoiesis of indeterminate potential (CHIP) variants, and epigenetic aging measures and then follow patients for ICI-associated cardiovascular disease (ICI-CVD), cancer progression, or death. The primary goal is to identify predictors of a composite outcome of ICI-CVD and cancer progression or death and to distinguish predictors specific to cardiotoxicity versus cancer response. The work is single-center and does not involve experimental treatments or changes to standard cancer therapy.

Who should consider this trial

Good fit: Adults aged 18 or older who plan to start immune checkpoint inhibitor therapy and can provide a baseline blood sample before treatment are the intended participants.

Not a fit: Patients who cannot provide a baseline blood sample before starting treatment or who are judged by the principal investigator not to be appropriate candidates for outcome evaluation would not be eligible and likely would not benefit from this study.

Why it matters

Potential benefit: If successful, this work could help doctors predict who is at higher risk of heart side effects from immunotherapy and personalize monitoring or treatment plans to protect the heart while preserving cancer benefit.

How similar studies have performed: Some components such as CHIP and metabolomic links to cardiovascular risk have supporting data, but combining CHIP, epigenetic aging, and HMDM-derived metabolomics to decouple ICI cardiotoxicity from cancer response is a novel approach with limited prior direct evidence.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Plan to start immune checkpoint inhibitor for cancer therapy

Exclusion Criteria:

1. No baseline blood collection prior to initiation
2. At time of evaluation not determined to be a good candidate for evaluation of outcome events by the principal investigator

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Nicolas Palaskas, MD — M.D. Anderson Cancer Center
• Study coordinator: Nicolas Palaskas, MD

Conditions: Tumor, Cardiovascular