A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events
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.
Detailed 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. Research blood samples and tumor tissue will be collected. All participants will be followed by phone call or medical record review for survival for up to three years. Participants who come off for reasons other than disease progression will also be followed with CT scans every 12 weeks until progression for up to two years.
Arms & interventions
- DrugSecukinumab Injection
Secukinumab 300mg subcutaneously
Outcome measures
Primary
Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Participants will be assessed for AEs at each study visit. AEs are graded by NCI-CTCAE v5.0 criteria.
Time frame: Until grade 3 side effect occurs or three years, whichever comes first
Feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Participants will be assessed for AEs at each study visit. AEs are graded by NCI-CTCAE v5.0 criteria.
Time frame: Until grade 3 side effect occurs or three years, whichever comes first
Eligibility criteria
Study locations (1)
Duke University Health System
Durham, North Carolina, 27710