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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283539
• Other study ID #: ircAE HS-3411
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: National Jewish Health
• Contact: Joanne Streib
• Phone: 303-398-1731
• Email: streibj[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: February 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Receiving, or prior to starting on, a checkpoint inhibitor

6. Grade = 2 ircAE (CTCAE v 5.0) (for cohort 1 only)

7. 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 pervious 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

Related Conditions & MeSH terms

• Cancer

Intervention

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)

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune Biomarkers	cytokines and chemokines	30 days
Secondary	Presence of skin and circulating lipid biomarkers which occur during and after ircAEs	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 F2a, 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
Secondary	Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE	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 F2a, 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