| Registry | NCT04283539 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 255 (Actual) |
| Sponsor | National Jewish Health (Other); collaborators: Memorial Sloan Kettering Cancer Center |
| Conditions | Cancer, Skin Disease, Immunotherapy, Patients With Solid Tumors Receiving Immunotherapy With an ICI Will be Randomized to Participate in an SDoH and Side Effects Navigation Program vs. Control |
| Interventions | systemic corticosteroid or biologic (Drug) |
| Dates | start 2020-09-23, primary completion 2025-03-25, completion 2026-02-28, first posted 2020-02-25, last updated 2026-06-16 |
| Locations | 3 sites in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CPI with ircAE | Drug: systemic corticosteroid or biologic | Participants on check point inhibitors with immune related cutaneous adverse event | |
| no ircAE | Participants who do not have a cutaneous adverse event |
Sex: All, ages: 18 Years to 99 Years
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. Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor 6. Grade ≥ 1 ircAE (CTCAE v 5.0) (for cohort 1 only) 7. No ircAE (cohort 2 only) 8. 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 previous 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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 | United States |