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

ircAE HS-3411

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.

2020-06-01

2024-06-01

2025-02-01

Recruiting

238

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 238, 'type': 'ESTIMATED'}}

2023-11-13