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NCT Number: NCT04283539

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

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.

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Key information

Conditions

Cancer Immunotherapy Neoplasms Patients With Solid Tumors Receiving Immunotherapy With an ICI Will be Randomized to Participate in an SDoH and Side Effects Navigation Program vs. Control Skin Disease Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, >18 yo
  • Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
  • Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor
  • Grade ≥ 1 ircAE (CTCAE v 5.0) (for cohort 1 only)
  • No ircAE (cohort 2 only)
  • An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
  • Life expectancy ≥ 12 weeks

Exclusion criteria

  • 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.
  • Enrollment in any investigational drug trial with a drug that has not been approved
  • Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
  • Pregnancy
  • Known blood borne infectious disease
  • Current or previous diagnosis of a leukemia or lymphoma
  • Unable to give consent for study participation
  • Life expectancy < 12 weeks
  • Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results

Treatment and study plan

systemic corticosteroid or biologic

Drug

Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)

Primary outcomes

  1. Immune Biomarkers

    Time frame: 30 days

    cytokines and chemokines

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 25, 2020
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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