MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-002307
    NCT ID: NCT02320305
    Sponsor Protocol Number: MC1177

About this study

This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Central pathology review submission; Note: this review for MART-1 positivity is mandatory prior to randomization to confirm eligibility
  • Human leukocyte antigen (HLA)-A2-positive
  • Histologic proof of stage II, III or IV melanoma that has been completely resected or completely treated with ablative therapy (ex: stereotactic body radiosurgery, radiofrequency ablation, cryoablation) with no current evidence of disease, as demonstrated by imaging within 2 months (stage III or stage IV; must be computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]/CT) or 6 months (stage II; may be chest x-ray, CT, MRI, or PET/CT)
  • Absolute neutrophil count (ANC) ≥ 1500 mL
  • Hemoglobin (Hgb) > 10 g/dL
  • Platelets (PLT) ≥ 50,000 mL
  • Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 x ULN
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow-up
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • For women of childbearing potential, a negative serum pregnancy test ≤ 7 days prior to registration
  • Willingness to provide mandatory blood samples for correlative research

Exclusion Criteria:

  • Uncontrolled or current infection
  • Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
  • Known allergy to any of the vaccine or adjuvant components, including eggs
  • Any of the following prior therapies with interval since most recent treatment:
    • Chemotherapy ≤ 4 weeks prior to registration
    • Biologic or immunologic therapy ≤ 4 weeks prior to registration
    • Radiation therapy ≤ 4 weeks prior to registration
  • Failure to fully recover from side effects of prior therapy or surgery
  • Any of the following:
    • Pregnant women
    • Nursing women
    • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Known immune deficiency, including human immunodeficiency virus (HIV) infection
  • History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
  • Current or recent (≤ 4 weeks) use of immunosuppressive medications including systemic (inhaled, oral, or intravenous [IV]) corticosteroids; Note: use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable
  • History of brain metastases; EXCEPTION: patients with a solitary brain metastasis that has been completely resected, and who have no ongoing central nervous system (CNS) symptoms and an MRI documenting no evidence of CNS disease at least 3 months after resection and within 30 days of registration, are eligible for treatment
  • Other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy > 5 years prior to registration, the patient must not be receiving other cancer treatment

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Block, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions