Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a psoriasis drug tame Immunotherapy's worst side effects?

NCT ID NCT07237594

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 4 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.