IL-17 Blockade to See if Restarting Immunotherapy is Safer in Metastatic Melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional trial examines the safety and feasibility of adding the IL-17A antibody secukinumab to prior immunotherapy in patients with advanced metastatic melanoma who previously experienced immune-related adverse events. Participants will receive secukinumab before their next immune checkpoint inhibitor (ICI) dose, then resume standard PD-1–based therapy with ongoing secukinumab every four weeks after an initial weekly period. Safety and adverse events will be monitored at each visit, with tumor response assessed by CT scans every 12 weeks using iRECIST/RECIST criteria, and survival followed for up to three years. Optional research samples include blood and tumor tissue collected during the study. Follow-up continues for patients who discontinue ICI for reasons other than progression, with imaging every 12 weeks for up to two years.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Histologically confirmed advanced metastatic melanoma
2. Participants of any gender who are at least 18 years of age on the day of signing informed consent
3. 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.
4. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
5. Participant must have had prior treatment with ICI therapy (either PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care) and experienced grade 2 or higher immune-related colitis, hepatitis, or skin rash leading to treatment interruption or discontinuation or requiring steroid administration (systemic or topical).

   * 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 Criteria:

1. Uveal melanoma
2. Any participants known to be pregnant or breastfeeding.
3. 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
4. Patients with symptomatic CNS metastases and/or carcinomatous meningitis

   * 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

Where it's running

• Duke University Health System
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: April Salama, MD — Duke University
• Study coordinator: April Salama, MD
• Email: april.salama@duke.edu
• Phone: +1 919 681 9507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.