# Project 2: I CARE (Immunotherapy Cutaneous Adverse events REsearch)

> **NIH NIH U54** · CITY COLLEGE OF NEW YORK · 2024 · $196,250

## Abstract

Project Summary: Immune checkpoint inhibitors (ICIs), widely used in cancer treatment, are associated with
the development of inflammatory and autoimmune conditions, referred to as immune-related adverse events
(irAEs), affecting up to 40-60% of those treated. IrAEs result in additional patient morbidity, decreased quality
of life, treatment stoppage, and increased mortality. Furthermore, outcomes in minoritized populations often
tend to be worse. Identifying individuals at poorest irAE outcome risk, and the underlying reasons, is critical for
pretherapy counseling, tailoring supportive care interventions, and potentially treating with alternate anticancer
regimens. Factors known to influence the development of irAEs include increased age, female gender, pre-
existing autoimmune disease, ICI targets, genetic factors (HLA-DRB), and pretherapy eosinophil and B cell
levels. However, there is limited understanding on the interplay of biologic factors, along with allostatic load and
social determinants of health (SDoH), in irAE immunobiology and patient outcomes, and little data on
interventions to mitigate irAE impact in minoritized and/or low socioeconomic status (SES) populations.
Cutaneous irAEs (ircAEs) provide a unique platform for irAE studies: they are the most common irAEs, are
often a precursor to other-organ-specific irAEs, and skin tissue is accessible for study. Thus, I CARE will focus
on ircAEs. I CARE will use biologic specimens from the U01 AR077511 (Identification of Pathways to Mitigate
Immune- Related Adverse Events with Cancer Immunotherapy; PIs: Leung, Lacouture, Kern) patient cohort, to
be diversified with additional enrollees, to further describe the immunobiology of ircAEs (Aim 1), and the
association of SDoH, allostatic load, and symptom severity (Aim 2). These data will then be used to inform the
implementation of an intensive patient navigation/side effects management intervention, to be tested in a 2-arm
pilot randomized controlled trial (versus usual and customary care), for its impact at 6 months on ICI continuation
(primary outcome); side effect occurrence, severity, and management; quality of life; and biological changes
(secondary outcomes) in a cohort of minoritized and/or low SES cancer patients receiving ICIs (Aim 3). The I
CARE study personnel will work with the U54 Linguistic & Cultural Responsiveness Shared Resource and
Community Outreach and Research Engagement cores to facilitate participant engagement
Relevance: Immune checkpoint inhibitors are immunotherapy drugs that treat various types of cancer, but up
to half of patients have adverse events from taking these drugs, with the result that they discontinue the drug
early, and may have worse quality of life or even shorter life expectancy. This study investigates whether these
adverse events are more likely to happen in patients from minoritized or poorer populations due to increased
life stress – and if so, what are the specific factors involved, to address t...

## Key facts

- **NIH application ID:** 11011997
- **Project number:** 2U54CA132378-16
- **Recipient organization:** CITY COLLEGE OF NEW YORK
- **Principal Investigator:** Bao Q Vuong
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $196,250
- **Award type:** 2
- **Project period:** 2008-09-26 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11011997

## Citation

> US National Institutes of Health, RePORTER application 11011997, Project 2: I CARE (Immunotherapy Cutaneous Adverse events REsearch) (2U54CA132378-16). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11011997. Licensed CC0.

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