Can a psoriasis drug tame Immunotherapy's worst side effects?
NCT ID NCT07237594
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether giving an IL-17 blocker (secukinumab) alongside restarting immunotherapy can lower the risk of severe immune-related side effects in people with advanced melanoma. Only 4 participants who previously had side effects like colitis or rash will be enrolled. The goal is to see if this approach is safe and feasible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 4 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Health System
RECRUITINGDurham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World melanoma care under the microscope
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can an immune booster make chemo hit melanoma harder?
- A quest to find biomarkers that match melanoma patients with the right immunotherapy
- Can a triple immunotherapy attack beat advanced melanoma?