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

National Jewish Health3 sites in 1 country238 target enrollmentJune 1, 2020

ConditionsCancer

Interventionssystemic corticosteroid or biologic

Drugssystemic corticosteroid or biologic

Overview

Phase: Not Applicable
Intervention: systemic corticosteroid or biologic
Conditions: Cancer
Sponsor: National Jewish Health
Enrollment: 238
Locations: 3
Primary Endpoint: Immune Biomarkers
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

February 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

National Jewish Health

Responsible Party

Principal Investigator

Jeffrey Kern

Professor of Medicine

National Jewish Health

Eligibility Criteria

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
•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

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
•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

Arms & Interventions

CPI with ircAE

Participants on check point inhibitors with immune related cutaneous adverse event

Intervention: systemic corticosteroid or biologic

Outcomes

Primary Outcomes

Immune Biomarkers

Time Frame: 30 days

cytokines and chemokines

Secondary Outcomes

Presence of skin and circulating lipid biomarkers which occur during and after ircAEs(30 days)
Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE(12 months)