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

National Jewish Health

Status: Enrolling

Conditions: Cancer

Treatments: Drug: systemic corticosteroid or biologic

Study type: Observational

Funder types: Other

Identifiers

NCT04283539

ircAE HS-3411

Details and patient eligibility

About

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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

238 participants in 2 patient groups

CPI with ircAE

Description:

Participants on check point inhibitors with immune related cutaneous adverse event

Treatment:

Drug: systemic corticosteroid or biologic

no ircAE

Description:

Participants who do not have a cutaneous adverse event