Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- National Jewish Health
- Enrollment
- 255
- Locations
- 5
- Primary Endpoint
- Immune Biomarkers
Study 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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •8. 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 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
Arms & Interventions
CPI with ircAE
Participants on check point inhibitors with immune related cutaneous adverse event
Intervention: systemic corticosteroid or biologic (Drug)
no ircAE
Participants who do not have a cutaneous adverse event
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)
Investigators
Jeffrey Kern
Professor of Medicine
National Jewish Health