IL-17 Blockade to Decrease irAEs (REPLAY)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07237594
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 12, 2026
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2030

Study Design

Enrollment
4 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab
    Participants will first undergo pre-treatment with secukinumab (300mg subcutaneously) within 1 to 7 days prior to resumption of ICI treatment. Participants will then undergo anti-PD-1 therapy, anti PD-1 plus anti LAG3 (relatlimab) or anti-PD-1 plus anti CTLA-4 therapy at the discretion of their treating physician. Participants will concurrently receive secukinumab 300mg subcutaneously weekly for the first 4 weeks of treatment and then every 4 weeks.

Primary Outcome Measure

Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs) [ Time Frame: Until grade 3 side effect occurs or three years, whichever comes first ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Duke University Health SystemDurhamNorth Carolina27710

Find similar trials in Durham, NC

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Duke University Health System· Durham, NC

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