NCT07237594

IL-17 Blockade to Decrease irAEs (REPLAY)

A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Secukinumab Injection	Secukinumab 300mg subcutaneously

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-06-30
• Completion: 2030-06-30
• First posted: 2025-11-20
• Last updated: 2026-03-11