A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients (MEL58)
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ClinicalTrials.gov Identifier: NCT01585350 |
Recruitment Status :
Completed
First Posted : April 25, 2012
Last Update Posted : August 12, 2016
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Condition or disease | Intervention/treatment | Phase |
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Melanoma | Biological: MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS) Biological: MELITAC 12.1 + Montanide ISA-51 + polyICLC | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients, With Evaluation of the Injection Site Microenvironment |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
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Experimental: Cohort 1
Vaccines will be administered subcutaneously, intradermally or transdermally in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on days 1, 8, 15, 36, 57, and 78. |
Biological: MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)
Cohort 1 will be divided into three sub-groups and will receive:
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Experimental: Cohort 2
Vaccines will be administered subcutaneously, intradermally or transdermally in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on days 1, 8, 15, 36, 57, and 78. |
Biological: MELITAC 12.1 + Montanide ISA-51 + polyICLC
Cohort 2 will be divided into three sub-groups and will receive:
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- Safety, with measures of adverse events, locally and systemically [ Time Frame: over 6 months ]
- CD8+ and CD4+ peptide-reactive T cell responses among lymphocytes in the peripheral blood and in sentinel immunized nodes (SIN) [ Time Frame: over 6 months ]
- Toll-like receptor signaling in the replicate immunization site [ Time Frame: over 6 months ]
- CCR and integrin expression on vaccine induced T cells in the peripheral blood and at the replicate immunization site [ Time Frame: over 6 months ]
- Th1, Th2, and Th17 profiles of T cells in the vaccination site and SIN as measured by cytokine expression (IFNγ, IL-2, TNFα, IL-4, IL-5, IL-10, IL-17, IL-23), and nuclear expression of transcription factors (T-bet, GATA3, RORγt) by immunohistochemistry. [ Time Frame: over 6 months ]
- Chemokines CXCL9, 10, and 11; CCL19, CCL21, CXCL12, CXCL13 in the vaccine site microenvironment [ Time Frame: over 6 months ]
- Markers of activation, regulation, and apoptosis on CD4 and CD8 T cells in the vaccine site and SIN: CD69, Ki67, FoxP3, and TUNEL staining [ Time Frame: over 6 months ]
- Homing receptors expressed by antigen-reactive (tetramer-positive) T cells induced by vaccination, in the circulation and SIN [ Time Frame: over 6 months ]
- MyD88 expression in the VSME and SIN [ Time Frame: over 6 months ]
- Regulatory processes in the immunization site and SIN [ Time Frame: over 6 months ]
- Regulatory T cells (CD4+CD25hi FoxP3+)
- Myeloid suppressor cells
- Indole-amine dioxygenase
- PD-1, B7-H1
- IL-10 and IL-12 expression by dendritic cells (DC)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histologically or cytologically proven melanoma that meets one of the following two criteria:
- Stage IIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
- Stage III or IV melanoma with disease. Patients may be eligible if there are definite or equivocal findings of persistent or metastatic disease as long as those findings do not meet RECIST criteria for measurable disease.
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Patients with brain metastases may be eligible if all of the following are true:
- The total number of brain metastases ever is less than or equal to 3.
- The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry.
- There has been no evident growth of any brain metastasis since treatment.
- No treated brain metastasis is greater than 2 cm in diameter at the time of protocol entry.
- Patients must have at least two intact axillary and/or inguinal lymph node basins.
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All patients must have:
- ECOG performance status of 0 or 1.
- Ability and willingness to give informed consent.
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Laboratory parameters as follows:
- HLA-A1, A2, A3, -A11, or -A31
- ANC > 1000/mm3
- Platelets > 100,000/mm3
- Hgb ≥ 9 g/dL
- AST and ALT ≤ 2.5 x upper limits of normal (ULN)
- Bilirubin ≤ 2.5 x ULN
- Alkaline Phosphatase ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN
- HIV negative
- Hepatitis C negative
- HGBA1C level of < 7%
Exclusion Criteria:
- Patients who have had brain metastases, unless they meet inclusion criteria
- Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study enrollment. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- Patients with clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation.
- Patients with known or suspected allergies to any component of the vaccine.
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Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
- Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids
- Allergy desensitization injections.
- Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair®, Flovent®, Azmacort®) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex®).
- Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
- Interferon therapy.
- Interleukin-2 or other interleukins.
- Toll-like receptor agonists, including imiquimod or resiquimod.
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Prior melanoma vaccinations may be an exclusion criterion in some circumstances:
- Patients who have recurred or progressed either after or during administration of a melanoma vaccine may be eligible to enroll 12 weeks following their last vaccination.
- Patients may have been vaccinated previously with peptide vaccines (except that they may not have been vaccinated with peptides included in MELITAC 12.1 or MELITAC 12.6)
- Patients may have been vaccinated with protein, DNA, or cell-based vaccines that include the proteins from which these peptides are derived.
- Other investigational drugs or investigational therapy if the patient is currently taking those drugs/therapy, or if they have received the drugs/therapy within 1 month.
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Women must also not be breast feeding.
- Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
- Patients classified as having Class III or IV heart disease according to the New York Heart Association
- Body weight < 110 lbs
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No active or prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following will not be exclusionary:
- The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without associated symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring NSAID medications or no medical therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585350
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Craig L Slingluff, MD | University of Virginia |
Responsible Party: | Craig L Slingluff, Jr, Director, Human Immune Therapy Center, University of Virginia |
ClinicalTrials.gov Identifier: | NCT01585350 |
Other Study ID Numbers: |
15781 |
First Posted: | April 25, 2012 Key Record Dates |
Last Update Posted: | August 12, 2016 |
Last Verified: | August 2016 |
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