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New treatment option for Metastatic Melanoma
Official title IL-17 Blockade to Decrease irAEs (REPLAY)
ClinicalTrials.gov ID: NCT07237594
What this study is testing
What is Secukinumab Injection?
Secukinumab Injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
- 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...
You likely can't join if
- 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...
- 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
- History of or active (non-infectious) pneumonitis that required steroids
See the full eligibility criteria
- 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...
- Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
- 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...
- Note that patients who experience more than one irAEs are eligible to participate
- 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
- 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...
- 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
- History of or active (non-infectious) pneumonitis that required steroids
- Active infection requiring systemic therapy
- Known history of Human Immunodeficiency Virus (HIV) infection
- Known history of Hepatitis B or known active Hepatitis C virus infection. NOTE: no testing for Hepatitis B or Hepatitis C is required
- Known history of active TB (Bacillus Tuberculosis)
- 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...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- History of allogenic tissue or solid organ transplant
- History of active autoimmune disease requiring systemic therapy within the past 12 months, with the exception of ICI induced irAEs.
- Has not been treated with secukinumab within the last 12 months
- History of prior cardiac, neurologic, ocular IRAE related to ICI; history of blistering cutaneous IRAE related to ICI
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.