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.
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
- Conditions the study is for
- Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma
- 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
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- 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.
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:
- 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:
- Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
- 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.
- Conditions
- Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
- 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 group | Role | What they receive |
|---|---|---|
| Arm I (MART-1 antigen and TLR4 antagonist GLA-SE) | Experimental | Patients 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) | Experimental | 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. 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.
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)
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.
- First posted19 Dec 2014 (estimated)
- Study start27 Jan 2015
- Primary completion7 Dec 2015
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stage IIA Skin MelanomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew Block, Principal investigator, Mayo Clinic
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 33955240Grewal 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT02320305
- Acronym / sponsor ID
- MC1177
- Conditions
- Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MART-1 antigen and TLR4 antagonist GLA-SE) | Experimental | Biological: MART-1 Antigen, Drug: TLR4 Agonist GLA-SE, Other: Laboratory Biomarker AnalysisPatients 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. |
| Arm II (MART-1 antigen) | Experimental | Biological: MART-1 Antigen, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Failure to fully recover from side effects of prior therapy or surgery
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 |
|---|---|---|
| MART-1 AntigenAlso: Antigen LB39-AA, Antigen SK29-AA, MART-1 Tumor AntigenGiven IM | Biological | Arm I (MART-1 antigen and TLR4 antagonist GLA-SE), Arm II (MART-1 antigen) |
| TLR4 Agonist GLA-SEAlso: GLA-SE, Glucopyranosyl Lipid A in Stable Emulsion, Glucopyranosyl Lipid Adjuvant-Stable Emulsion, Toll-like Receptor 4 Agonist GLA-SEGiven IM | Drug | Arm I (MART-1 antigen and TLR4 antagonist GLA-SE) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (MART-1 antigen and TLR4 antagonist GLA-SE), Arm II (MART-1 antigen) |
Primary outcome
Immune response
Time frame: Up to 24 months
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.
1 secondary outcome
Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 33955240Kobayashi 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.
- Derived from this study: PubMed 32752904Grewal 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.
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. This study is not recruiting at the moment.
Matthew Block principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.