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.
Who can participate
Age range18 Years
SexALL
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✓. Participants of any gender who are at least 18 years of age on the day of signing informed consent
✓. 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.
✓. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
✓. Participant must have had prior treatment with ICI therapy (either PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care) and experienced grade 2 or higher immune-related colitis, hepatitis, or skin rash leading to treatment interruption or discontinuation or requiring steroid administration (systemic or topical).
✓. Adequate organ function as defined below. Standard of care labs drawn within 42 days prior to consent may be used for the purposes of determining eligibility.
Exclusion criteria
✕. Uveal melanoma
✕. Any participants known to be pregnant or breastfeeding.
✕. Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy
What they're measuring
1
Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Timeframe: Until grade 3 side effect occurs or three years, whichever comes first
2
Feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Timeframe: Until grade 3 side effect occurs or three years, whichever comes first