A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events
Duke University
Summary
The primary objective of this study is to determine the safety and feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody, (Secukinumab, Cosentyx®) to participants with metastatic melanoma who have previously received immune checkpoint inhibitor (ICI) therapy, experienced an immune related adverse event (colitis, hepatitis, skin rash, psoriatic arthritis) to ICI, and are re-initiating ICI therapy.
Description
Participants will receive pre-treatment (pre-ICI) with secukinumab (300mg) within 1 to 7 days prior to the initial ICI dose. Participants will then resume ICI therapy (the specific ICI agent and dose are determined by the treating physician per their standard practice). Participants will receive secukinumab weekly for the first 4 weeks, and then once every 4 weeks thereafter until grade 3 side effect occurs or ICI is discontinued. Participants will have AE (adverse event) assessments at each study visit. Disease assessments via CT scans will be performed every 12 weeks with iRECIST/RECIST. Re…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Histologically confirmed advanced metastatic melanoma 2. Participants of any gender who are at least 18 years of age on the day of signing informed consent 3. Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care. Patients should either be restarting the same ICI regimen which contributed to the prior toxicity or have a clinical need to escalate to doublet (combination) ICI therapy, plan for therapy should be reviewed by the PI of this study. 4. Participan…
Interventions
- DrugSecukinumab Injection
Secukinumab 300mg subcutaneously
Location
- Duke University Health SystemDurham, North Carolina