Cancer, 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, Skin Disease
Conditions
Keywords
checkpoint inhibitor, immuno-oncology, cutaneous adverse events, immunotherapy
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.
Interventions
DRUGsystemic corticosteroid or biologic
Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
Sponsors
National Jewish Health
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Biomarkers | 30 days | cytokines and chemokines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of skin and circulating lipid biomarkers which occur during and after ircAEs | 30 days | Proportion of long-chain and short-chain ceramides Amounts and relative proportion of lysophosphatidylcholine molecular species. sphingosine-1-phosphate, platelet activating factor, leukotriene E4, prostaglandin F2α, endocannabinoids anandamide and 2- arachidonoylglycerol. Peripheral blood mononuclear cell RNA for expression of GRalpha, GRbeta, Vitamin D 24- Hydroxylase FK506 binding protein 5, mitogen induced kinase phosphatase 1, interleukin, tumor necrosis factor alphal |
| Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE | 12 months | Proportion of long-chain and short-chain ceramides Amounts and relative proportion of lysophosphatidylcholine molecular species. sphingosine-1-phosphate, platelet activating factor, leukotriene E4, prostaglandin F2α, endocannabinoids anandamide and 2- arachidonoylglycerol. Peripheral blood mononuclear cell RNA for expression of GRalpha, GRbeta, Vitamin D 24- Hydroxylase FK506 binding protein 5, mitogen induced kinase phosphatase 1, interleukin, tumor necrosis factor alphal |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald Leung, MD, PhD
National Jewish Health
Outcome results
None listed