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

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ClinicalTrials.gov Identifier: NCT04283539
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Kern, National Jewish Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer Drug: systemic corticosteriod or biologic

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Study Type : Observational
Estimated Enrollment : 238 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Group/Cohort Intervention/treatment
CPI with ircAE
Participants on check point inhibitors with immune related cutaneous adverse event
Drug: systemic corticosteriod 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



Primary Outcome Measures :
  1. Immune Biomarkers [ Time Frame: 30 days ]
    cytokines and chemokines


Secondary Outcome Measures :
  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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male or female with diagnosis of solid tumor
Criteria

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 genitourinary/gynecologic, lung, gastrointestinal and melanoma
  5. Grade ≥ 2 ircAE (CTCAE v 5.0) (waived for control cohort that does not develop ircAE)
  6. ircAE treatment with systemic corticosteroids or biologic therapies as determined by the treating physician
  7. Life expectancy ≥ 12 weeks

Exclusion Criteria:

  1. Current use of systemic steroid treatment in the past 4 weeks (prednisone >10mg a day or equivalent)
  2. Enrollment in any investigational drug trial within 60 days.
  3. Taking other systemic immunomodulators beyond anti-PD-(L)-1 or anti-CTLA-4
  4. Concomitant cytotoxic chemotherapy, targeted therapy, or radiation therapy
  5. Pregnancy
  6. Unable to give consent for study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283539


Locations
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United States, Colorado
National Jewish Health and University of Colorado Denver
Denver, Colorado, United States, 80206
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Mario Lacouture, MD    646-608-2374    LacoutuM@mskcc.org   
Sponsors and Collaborators
National Jewish Health
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Responsible Party: Jeffrey Kern, Professor of Medicine, National Jewish Health
ClinicalTrials.gov Identifier: NCT04283539    
Other Study ID Numbers: ircAE HS-3411
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Kern, National Jewish Health:
checkpoint inhibitor
immuno-oncology
cutaneous adverse events