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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Secukinumab Injection
DrugSecukinumab 300mg subcutaneously
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: SecukinumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 first2
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 firstSponsors and contacts
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Source ClinicalTrials.gov