IL-17 Blockade to Decrease irAEs (REPLAY)
ConditionMetastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
Qualifiers
Histologically confirmed advanced metastatic melanoma
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
Disqualifiers
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
Patients with symptomatic CNS metastases and/or carcinomatous meningitis
Trial design
Treatments tested in this trial
- Secukinumab Injection
Treatment groups
4 Participants
are divided into 1 treatment groupLocations
1Duke University Health System27710, DurhamNorth Carolina, United States
Sponsors and collaborators
Duke University
Lead sponsor
Source ClinicalTrials.gov