Durham, NCNCT07237594Now EnrollingIRB Ready

Metastatic Melanoma Clinical Trial in Durham, NC

Access cutting-edge metastatic melanoma treatment through this phase 1 clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Duke University

Quick Self-Assessment

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Expert Care in Durham

Access metastatic melanoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic melanoma treatment provided free

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Check if you qualify for this metastatic melanoma clinical trial in Durham, NC

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Durham site if eligible
  4. 4Begin participation

About This Metastatic Melanoma Study in Durham

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.

Sponsor: Duke University

Who Can Participate

Inclusion 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 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
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

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
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT07237594) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Melanoma Treatment Options in Durham, NC

If you're searching for metastatic melanoma treatment options in Durham, NC, this clinical trial (NCT07237594) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced metastatic melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic melanoma clinical trials near you to find additional studies recruiting in your area.

More Melanoma Trials in Durham, NC

See all melanoma clinical trials recruiting in Durham — not just this study.

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Secure · Expert Care · Durham, NC