Metastatic MelanomaPhase 1REPLAYNCT07237594
IL-17 Blockade to Decrease irAEs (REPLAY)
A Phase 1 study testing Secukinumab Injection in people with Metastatic Melanoma, run by Duke University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Secukinumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 30 Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
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- 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
Who cannot join
- 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
- 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
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- 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 the best interest of the subject to participate, in the opinion of the treating physician
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Bolch contact
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
April Salama, MD
About this study
Official title: A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events
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.
Read the detailed description
Participants will receive pre-treatment (pre-ICI) with secukinumab (300mg) within 1 to 7 days prior to the initial ICI dose. Participants will then resume ICI therapy (the specific ICI agent and dose are determined by the treating physician per their standard practice). Participants will receive secukinumab weekly for the first 4 weeks, and then once every 4 weeks thereafter until grade 3 side effect occurs or ICI is discontinued.
Participants will have AE (adverse event) assessments at each study visit. Disease assessments via CT scans will be performed every 12 weeks with iRECIST/RECIST. Research blood samples and tumor tissue will be collected. All participants will be followed by phone call or medical record review for survival for up to three years. Participants who come off for reasons other than disease progression will also be followed with CT scans every 12 weeks until progression for up to two years.
- Conditions
- Metastatic Melanoma
- Being tested
- Secukinumab Injection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab InjectionDrug
Secukinumab 300mg subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Participants will first undergo pre-treatment with secukinumab (300mg subcutaneously) within 1 to 7 days prior to resumption of ICI treatment. Participants will then undergo anti-PD-1 therapy, anti PD-1 plus anti LAG3 (relatlimab) or anti-PD-1 plus anti CTLA-4 therapy at the discretion of their treating physician. Participants will concurrently receive secukinumab 300mg subcutaneously weekly for the first 4 weeks of treatment and then every 4 weeks. Receives: Drug: Secukinumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until grade 3 side effect occurs or three years, whichever comes first
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.
Measured: Until grade 3 side effect occurs or three years, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start12 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April Salama, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237594
- Sponsor's protocol ID
- Pro00118701
- Acronym
- REPLAY
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events
- ClinicalTrials.gov ID
- NCT07237594
- Acronym / sponsor ID
- REPLAY / Pro00118701
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will receive pre-treatment (pre-ICI) with secukinumab (300mg) within 1 to 7 days prior to the initial ICI dose. Participants will then resume ICI therapy (the specific ICI agent and dose are determined by the treating physician per their standard practice). Participants will receive secukinumab weekly for the first 4 weeks, and then once every 4 weeks thereafter until grade 3 side effect occurs or ICI is discontinued.
Participants will have AE (adverse event) assessments at each study visit. Disease assessments via CT scans will be performed every 12 weeks with iRECIST/RECIST. Research blood samples and tumor tissue will be collected. All participants will be followed by phone call or medical record review for survival for up to three years. Participants who come off for reasons other than disease progression will also be followed with CT scans every 12 weeks until progression for up to two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: Secukinumab InjectionParticipants will first undergo pre-treatment with secukinumab (300mg subcutaneously) within 1 to 7 days prior to resumption of ICI treatment. Participants will then undergo anti-PD-1 therapy, anti PD-1 plus anti LAG3 (relatlimab) or anti-PD-1 plus anti CTLA-4 therapy at the discretion of their treating physician. Participants will concurrently receive secukinumab 300mg subcutaneously weekly for the first 4 weeks of treatment and then every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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).
Key exclusion criteria (16 listed)
- 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
- History of or active (non-infectious) pneumonitis that required steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab InjectionSecukinumab 300mg subcutaneously | Drug | Secukinumab |
Primary outcome
Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Time frame: Until grade 3 side effect occurs or three years, whichever comes first
Participants will be assessed for AEs at each study visit. AEs are graded by NCI-CTCAE v5.0 criteria.
Feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)
Time frame: Until grade 3 side effect occurs or three years, whichever comes first
Participants will be assessed for AEs at each study visit. AEs are graded by NCI-CTCAE v5.0 criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Bolch contact
April Salama, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Secukinumab Injection in people with Metastatic Melanoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact April Salama, MD (+1 919 681 9507, april.salama@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs) (time frame: Until grade 3 side effect occurs or three years, whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.