Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
- Conditions
- Cancer
- Interventions
- Drug: systemic corticosteroid or biologic
- Registration Number
- NCT04283539
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 238
- 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
- Receiving, or prior to starting on, a checkpoint inhibitor
- Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only)
- An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
- Life expectancy ≥ 12 weeks
- 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 pervious 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CPI with ircAE systemic corticosteroid or biologic Participants on check point inhibitors with immune related cutaneous adverse event
- Primary Outcome Measures
Name Time Method Immune Biomarkers 30 days cytokines and chemokines
- Secondary Outcome Measures
Name Time Method Presence of skin and circulating lipid biomarkers which occur during and after ircAEs 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 alphalMechanisms associated with corticosteroid unresponsiveness in patients with ircAE 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
Trial Locations
- Locations (3)
National Jewish Health
🇺🇸Denver, Colorado, United States
The Melanoma and Skin Cancer Institute
🇺🇸Denver, Colorado, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States