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Stage IIA Skin MelanomaEarly Phase 1NCT02320305

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

A Early Phase 1 study testing MART-1 Antigen, TLR4 Agonist GLA-SE and Laboratory Biomarker Analysis in people with Stage IIA Skin Melanoma and Stage IIB Skin Melanoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MART-1 Antigen, TLR4 Agonist GLA-SE and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
27 Jan 2015to 11 Apr 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the immune response of each immunization regimen to determine an optimal regimen in terms of immune response to recommend for phase II testing.

SECONDARY OBJECTIVES:

  1. Evaluate the adverse events profile of each immunization regimen.

TERTIARY OBJECTIVES:

  1. Describe the immunological efficacy of the vaccine preparations as measured by the frequency and interferon (IFN) gamma production of peptide-specific cytotoxic T lymphocytes (CTL).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive MART-1 antigen and TLR4 antagonist GLA-SE intramuscularly (IM) on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, stage II patients are followed up at 10 weeks and then at 6, 12, 18, and 24 months and stage III-IV patients are followed up at 3, 6, 9, 12, 15, 18, 21, and 24 months.

Being tested
MART-1 Antigen, TLR4 Agonist GLA-SE, Laboratory Biomarker Analysis
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MART-1 AntigenBiological

    Also called Antigen LB39-AA, Antigen SK29-AA, MART-1 Tumor Antigen

    Given IM

  • TLR4 Agonist GLA-SEDrug

    Also called GLA-SE, Glucopyranosyl Lipid A in Stable Emulsion, Glucopyranosyl Lipid Adjuvant-Stable Emulsion, Toll-like Receptor 4 Agonist GLA-SE

    Given IM

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02320305
Study groupRoleWhat they receive
Arm I (MART-1 antigen and TLR4 antagonist GLA-SE)ExperimentalPatients receive MART-1 antigen and TLR4 antagonist GLA-SE IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: MART-1 Antigen; Drug: TLR4 Agonist GLA-SE; Other: Laboratory Biomarker Analysis
Arm II (MART-1 antigen)ExperimentalPatients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: MART-1 Antigen; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response

    A patient is considered to have achieved an immune response if there is a 2-fold or more increase from pre-treatment levels in the absolute number of vaccine peptide-specific (MART-1a-specific) CTL as measured by tetramer staining, or if the frequency of MART-1a-specific CTL is initially undetectable (< 0.05% of CD8 T cells) and becomes detectable during the vaccine treatment period. The proportion of successes will be estimated and the exact binomial 95% confidence intervals for the true immune response rate will be calculated.

    Measured: Up to 24 months

Secondary outcomes (1)

  1. Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2014 (estimated)
  2. Study start27 Jan 2015
  3. Primary completion7 Dec 2015
  4. Study completion11 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02320305
Sponsor's protocol ID
MC1177
Other IDs
NCI-2014-02479, MC1177, P30CA015083
Status last verified
Feb 2019
First submitted
15 Dec 2014
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Kobayashi RH, Mandujano JF, Rehman SM, Kobayashi AL, Geng B, Atkinson TP, Melamed I, Turpel-Kantor E, Clodi E, Gupta S. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig(R) [octanorm]). Immunotherapy. 2021 Jul;13(10):813-824. doi: 10.2217/imt-2021-0064. Epub 2021 May 6.

    PubMed 33955240

  • Grewal EP, Erskine CL, Nevala WK, Allred JB, Strand CA, Kottschade LA, McWilliams RR, Dronca RS, Yakovich AJ, Markovic SN, Block MS. Peptide vaccine with glucopyranosyl lipid A-stable oil-in-water emulsion for patients with resected melanoma. Immunotherapy. 2020 Sep;12(13):983-995. doi: 10.2217/imt-2020-0085. Epub 2020 Aug 5.

    PubMed 32752904

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MART-1 Antigen, TLR4 Agonist GLA-SE and Laboratory Biomarker Analysis in people with Stage IIA Skin Melanoma and Stage IIB Skin Melanoma, run by Mayo Clinic 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 14 inclusion and 17 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: finished, as of the sponsor's last update on 14 Jan 2020. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune response (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02320305, which also lists 2 linked publications.

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 14 Jan 2020.

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