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REPLAY Study: Secukinumab for Metastatic Melanoma

This study is looking at whether giving a drug called secukinumab (Cosentyx®) can help reduce immune-related side effects (irAEs) in people with metastatic melanoma. These side effects can happen when you receive immune checkpoint inhibitor (ICI) therapy, which is a common treatment for melanoma. You might be able to join if you have metastatic melanoma, are at least 18 years old, and are planning to restart ICI therapy after experiencing an irAE from a previous ICI treatment. The study will look at how safe and practical it is to give secukinumab before and during your ICI therapy. The goal is to see if secukinumab can prevent or lessen these side effects, which could make ICI therapy easier to tolerate. This study plans to enroll 4 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a small study, planning to enroll 4 participants.
What's involved
You would receive secukinumab injections before and during your ICI therapy, weekly for the first 4 weeks, then every 4 weeks. You will have adverse event assessments at each study visit and CT scans every 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
You will be followed by phone or medical record review for survival for up to three years. If you stop treatment for reasons other than disease progression, you will have CT scans every 12 weeks for up to two years.

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NCT07237594

IL-17 Blockade to Decrease irAEs (REPLAY)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Duke University
~4 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Secukinumab Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Measured over Until grade 3 side effect occurs or three years, whichever comes first
+1 more outcome measured

Conditions

Metastatic Melanoma

Explore related trials

MelanomaInterleukin-17A

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • April Salama, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

April Salama, MD
[email protected]
+1 919 681 9507
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Note that patients who experience more than one irAEs are eligible to participate 6. 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.
Absolute Neutrophil Count (ANC) ≥ 1500/µL
Platelets ≥ 100,000/µL
Hemoglobin\* ≥ 9.0 g/dL or ≥ 5.6 mmol/L \*Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the previous 2 weeks
AST/ALT 2.5x upper limit of normal

Exclusion

Patients with asymptomatic, clinically stable CNS metastases are allowed provided they do not require steroid treatment 5. History of or active (non-infectious) pneumonitis that required steroids 6. Active infection requiring systemic therapy 7. Known history of Human Immunodeficiency Virus (HIV) infection 8. Known history of Hepatitis B or known active Hepatitis C virus infection. NOTE: no testing for Hepatitis B or Hepatitis C is required 9. Known history of active TB (Bacillus Tuberculosis) 10. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician 11. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 12. History of allogenic tissue or solid organ transplant 13. History of active autoimmune disease requiring systemic therapy within the past 12 months, with the exception of ICI induced irAEs. 14. Has not been treated with secukinumab within the last 12 months 15. History of prior cardiac, neurologic, ocular IRAE related to ICI; history of blistering cutaneous IRAE related to ICI

What this trial measures

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

    Participants will be assessed for AEs at each study visit. AEs are graded by NCI-CTCAE v5.0 criteria.

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

    Participants will be assessed for AEs at each study visit. AEs are graded by NCI-CTCAE v5.0 criteria.