Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

June 12, 2026 updated by: Jeffrey Kern, National Jewish Health
This protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.

In addition, this 2-arm pilot randomized controlled trial evaluating the impact of a patient navigation/side effects management intervention versus usual and customary care, on immune checkpoint inhibitor (ICI) continuation at 6 months (primary outcome) as well as occurrence, severity, and management of immune-related AEs (irAEs); quality of life; and progression-free survival (PFS) (secondary outcomes) in a cohort of minoritized and/or low socioeconomic status (SES) cancer patients receiving ICIs.

Study Type

Observational

Enrollment (Actual)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
      • Denver, Colorado, United States, 80206
        • The Melanoma and Skin Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult male or female with diagnosis of solid tumor

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, >18 yo
  4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
  5. Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor
  6. Grade ≥ 1 ircAE (CTCAE v 5.0) (for cohort 1 only)
  7. No ircAE (cohort 2 only)
  8. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)

8. Life expectancy ≥ 12 weeks

Exclusion Criteria:

  1. Daily use of systemic steroid treatment in the past 4 weeks (prednisone >10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions.
  2. Enrollment in any investigational drug trial with a drug that has not been approved
  3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
  4. Pregnancy
  5. Known blood borne infectious disease
  6. Current or previous diagnosis of a leukemia or lymphoma
  7. Unable to give consent for study participation
  8. Life expectancy < 12 weeks
  9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CPI with ircAE
Participants on check point inhibitors with immune related cutaneous adverse event
Drug: systemic corticosteroid or biologic
Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
no ircAE
Participants who do not have a cutaneous adverse event

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Biomarkers
Time Frame: 30 days
cytokines and chemokines
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of skin and circulating lipid biomarkers which occur during and after ircAEs
Time Frame: 30 days

Proportion of long-chain and short-chain ceramides Amounts and relative proportion of lysophosphatidylcholine molecular species. sphingosine-1-phosphate, platelet activating factor, leukotriene E4, prostaglandin F2α, endocannabinoids anandamide and 2- arachidonoylglycerol.

Peripheral blood mononuclear cell RNA for expression of GRalpha, GRbeta, Vitamin D 24- Hydroxylase FK506 binding protein 5, mitogen induced kinase phosphatase 1, interleukin, tumor necrosis factor alphal
30 days
Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE
Time Frame: 12 months

Proportion of long-chain and short-chain ceramides Amounts and relative proportion of lysophosphatidylcholine molecular species. sphingosine-1-phosphate, platelet activating factor, leukotriene E4, prostaglandin F2α, endocannabinoids anandamide and 2- arachidonoylglycerol.

Peripheral blood mononuclear cell RNA for expression of GRalpha, GRbeta, Vitamin D 24- Hydroxylase FK506 binding protein 5, mitogen induced kinase phosphatase 1, interleukin, tumor necrosis factor alphal
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Donald Leung, MD, PhD, National Jewish Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2020

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ircAE HS-3411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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