Decoupling Immunotherapy Toxicity and Cancer Response

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Cardiovascular; Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT07382752

2025-1571

NCI-2025-09341 (Other Identifier)

Details and patient eligibility

About

This study is a novel evaluation of cardiotoxicity after ICI therapy based on traditional CV risk factors with the addition of metabolomic profiles, epigenetic aging, and CHIP. It is not an extension of previous work in ICI therapy.

Full description

Primary Objectives:

To identify predictors of a composite outcome comprising immune checkpoint inhibitor associated cardiovascular disease (ICI-CVD) and/or cancer progression or death.

To decouple the predictors of ICI-CVD and cancer treatment efficacy.

Secondary Objectives:

To identify human monocyte derived macrophages (HMDM)-derived metabolite signatures predictive of cardiovascular toxicity and cancer outcomes in ICI-treated patients.

To identify genetic (CHIP) and epigenetic age determinants of ICI-CVD and cancer outcomes in ICI-treated patients.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Prospective Observational Cohort

Description:

Utilizing baseline biospecimens for analysis of predictors of cardiotoxicity events and cancer outcomes after ICI initiation.