MelanomaPhase 1MEL58NCT01585350
A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients
A Phase 1 study testing MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS) and MELITAC 12.1 + Montanide ISA-51 + polyICLC in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1) combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and Montanide ISA-51. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS) and MELITAC 12.1 + Montanide ISA-51 + polyICLC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2014
- Phase
- 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
- 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.
- 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.
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- 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.
- All patients must have:
- ECOG performance status of 0 or 1.
- Ability and willingness to give informed consent.
- 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%
Who cannot join
- 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.
- 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
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- 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.
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients, With Evaluation of the Injection Site Microenvironment
The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1) combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at whether the experimental vaccine and these drugs cause any changes to the immune system.
Read the detailed description
Goals:
- To determine the safety of intradermal and subcutaneous injection of lipopolysaccharide (LPS) as a vaccine adjuvant with a multipeptide vaccine.
- To obtain preliminary data on whether administration of a multipeptide vaccine plus each of 2 TLR agonists is immunogenic with or without Incomplete Freund's Adjuvant (IFA)
- To obtain preliminary data on whether addition of either of 2 toll-like receptor (TLR) agonists improve the persistence of circulating CD8+ T cell responses to vaccination with a multipeptide vaccine.
- To determine the local and systemic toxicities of administration of a multipeptide vaccine with each of 2 TLR agonists, and with or without incomplete Freund's adjuvant.
- To determine the cytokine and chemokine profile of the vaccine-site microenvironment week 1 after injection of a multipeptide vaccine and each of 2 TLR agonists, with or without IFA.
- To obtain preliminary data on T cell activation status and apoptosis in the vaccine site microenvironment (VSME) as a function of vaccine adjuvant.
- To assess whether circulating CD8 T cells induced by vaccination express different homing receptor profiles (CLA, CXCR3, α4β1 integrin, α4β7 integrin).
- To evaluate dendritic cell activation and function in sentinel immunized nodes draining the site of vaccination, for production of IDO, arginase, IL10, IL12.
- To characterize MyD88 expression in dendritic cells infiltrating vaccination sites.
- To identify regulatory processes in the vaccination site.
Design: This is an open-label, randomized, pilot study of cellular and molecular events at the cutaneous site of immunization with a multipeptide vaccine. This and related peptide vaccines have been associated with immunologic efficacy in a majority of participants and have been associated with clinical tumor regressions in some participants. The maximum number of participants accrued will be 51.
Endpoints:
Primary:
- Safety, with measures of adverse events, locally and systemically
- CD8+ and CD4+ peptide-reactive T cell responses among lymphocytes in the peripheral blood and in sentinel immunized nodes (SIN)
Secondary:
- Toll-like receptor signaling in the replicate immunization site
- CCR and integrin expression on vaccine induced T cells in the peripheral blood and at the replicate immunization site
- 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.
- Chemokines CXCL9, 10, and 11; CCL19, CCL21, CXCL12, CXCL13 in the vaccine site microenvironment.
- Markers of activation, regulation, and apoptosis on CD4 and CD8 T cells in the vaccine site and SIN: CD69, Ki67, FoxP3, and TUNEL staining.
- Homing receptors expressed by antigen-reactive (tetramer-positive) T cells induced by vaccination, in the circulation and SIN.
- MyD88 expression in the VSME and SIN
- Regulatory processes in the immunization site and SIN
- 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)
- Conditions
- Melanoma
- Being tested
- MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS), MELITAC 12.1 + Montanide ISA-51 + polyICLC
- Keywords
- melanoma, peptide vaccine, polyICLC, lipopolysaccharide (LPS), immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)Biological
Cohort 1 will be divided into three sub-groups and will receive:
- Group 1a: MELITAC 12.1 + lipopolysaccharide (LPS)
- Group 1b: MELITAC 12.1 + lipopolysaccharide (LPS) + Montanide adjuvant with vaccination #1
- Group 1c: MELITAC 12.1 + lipopolysaccharide (LPS) adjuvant + Montanide adjuvant with all vaccinations
MELITAC 12.1 + Montanide ISA-51 + polyICLCBiological
Cohort 2 will be divided into three sub-groups and will receive:
- Group 2a: MELITAC 12.1 + polyICLC adjuvant
- Group 2b: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with vaccination #1
- Group 2c: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with all vaccinations
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Biological: MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS) |
| Cohort 2 | Experimental | 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. Receives: Biological: MELITAC 12.1 + Montanide ISA-51 + polyICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, with measures of adverse events, locally and systemically
Measured: over 6 months
CD8+ and CD4+ peptide-reactive T cell responses among lymphocytes in the peripheral blood and in sentinel immunized nodes (SIN)
Measured: over 6 months
Secondary outcomes (8)
Toll-like receptor signaling in the replicate immunization site
Measured: over 6 months
CCR and integrin expression on vaccine induced T cells in the peripheral blood and at the replicate immunization site
Measured: 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.
Measured: over 6 months
Chemokines CXCL9, 10, and 11; CCL19, CCL21, CXCL12, CXCL13 in the vaccine site microenvironment
Measured: 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
Measured: over 6 months
Homing receptors expressed by antigen-reactive (tetramer-positive) T cells induced by vaccination, in the circulation and SIN
Measured: over 6 months
MyD88 expression in the VSME and SIN
Measured: over 6 months
Regulatory processes in the immunization site and SIN
- 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)
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionOct 2014
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 MelanomaStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, National Cancer Institute (NCI), Oncovir, Inc.
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L Slingluff, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585350
- Sponsor's protocol ID
- 15781
- Acronym
- MEL58
- Status last verified
- Aug 2016
- First submitted
- 24 Apr 2012
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pollack KE, Meneveau MO, Melssen MM, Lynch KT, Koeppel AF, Young SJ, Turner S, Kumar P, Sol-Church K, Mauldin IS, Slingluff CL Jr. Incomplete Freund's adjuvant reduces arginase and enhances Th1 dominance, TLR signaling and CD40 ligand expression in the vaccine site microenvironment. J Immunother Cancer. 2020 Apr;8(1):e000544. doi: 10.1136/jitc-2020-000544.
PubMed 32350119Melssen MM, Petroni GR, Chianese-Bullock KA, Wages NA, Grosh WW, Varhegyi N, Smolkin ME, Smith KT, Galeassi NV, Deacon DH, Gaughan EM, Slingluff CL Jr. A multipeptide vaccine plus toll-like receptor agonists LPS or polyICLC in combination with incomplete Freund's adjuvant in melanoma patients. J Immunother Cancer. 2019 Jun 27;7(1):163. doi: 10.1186/s40425-019-0625-x.
PubMed 31248461
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients, With Evaluation of the Injection Site Microenvironment
- ClinicalTrials.gov ID
- NCT01585350
- Acronym / sponsor ID
- MEL58 / 15781
- Conditions
- Melanoma
- Keywords
- melanoma, peptide vaccine, polyICLC, lipopolysaccharide (LPS), immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- University of Virginia, National Cancer Institute (NCI), Oncovir, Inc.
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Apr 2012 (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.
The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1) combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at whether the experimental vaccine and these drugs cause any changes to the immune system.
Detailed description
Goals:
- To determine the safety of intradermal and subcutaneous injection of lipopolysaccharide (LPS) as a vaccine adjuvant with a multipeptide vaccine.
- To obtain preliminary data on whether administration of a multipeptide vaccine plus each of 2 TLR agonists is immunogenic with or without Incomplete Freund's Adjuvant (IFA)
- To obtain preliminary data on whether addition of either of 2 toll-like receptor (TLR) agonists improve the persistence of circulating CD8+ T cell responses to vaccination with a multipeptide vaccine.
- To determine the local and systemic toxicities of administration of a multipeptide vaccine with each of 2 TLR agonists, and with or without incomplete Freund's adjuvant.
- To determine the cytokine and chemokine profile of the vaccine-site microenvironment week 1 after injection of a multipeptide vaccine and each of 2 TLR agonists, with or without IFA.
- To obtain preliminary data on T cell activation status and apoptosis in the vaccine site microenvironment (VSME) as a function of vaccine adjuvant.
- To assess whether circulating CD8 T cells induced by vaccination express different homing receptor profiles (CLA, CXCR3, α4β1 integrin, α4β7 integrin).
- To evaluate dendritic cell activation and function in sentinel immunized nodes draining the site of vaccination, for production of IDO, arginase, IL10, IL12.
- To characterize MyD88 expression in dendritic cells infiltrating vaccination sites.
- To identify regulatory processes in the vaccination site.
Design: This is an open-label, randomized, pilot study of cellular and molecular events at the cutaneous site of immunization with a multipeptide vaccine. This and related peptide vaccines have been associated with immunologic efficacy in a majority of participants and have been associated with clinical tumor regressions in some participants. The maximum number of participants accrued will be 51.
Endpoints:
Primary:
- Safety, with measures of adverse events, locally and systemically
- CD8+ and CD4+ peptide-reactive T cell responses among lymphocytes in the peripheral blood and in sentinel immunized nodes (SIN)
Secondary:
- Toll-like receptor signaling in the replicate immunization site
- CCR and integrin expression on vaccine induced T cells in the peripheral blood and at the replicate immunization site
- 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.
- Chemokines CXCL9, 10, and 11; CCL19, CCL21, CXCL12, CXCL13 in the vaccine site microenvironment.
- Markers of activation, regulation, and apoptosis on CD4 and CD8 T cells in the vaccine site and SIN: CD69, Ki67, FoxP3, and TUNEL staining.
- Homing receptors expressed by antigen-reactive (tetramer-positive) T cells induced by vaccination, in the circulation and SIN.
- MyD88 expression in the VSME and SIN
- Regulatory processes in the immunization site and SIN
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)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. |
| Cohort 2 | Experimental | Biological: MELITAC 12.1 + Montanide ISA-51 + polyICLCVaccines 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically or cytologically proven melanoma that meets one of the following two criteria:
- Patients with brain metastases may be eligible if all of the following are true:
- Patients must have at least two intact axillary and/or inguinal lymph node basins.
- All patients must have:
- Laboratory parameters as follows:
Key exclusion criteria (26 listed)
- 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.
- Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
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 |
|---|---|---|
| MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)Cohort 1 will be divided into three sub-groups and will receive: * Group 1a: MELITAC 12.1 + lipopolysaccharide (LPS) * Group 1b: MELITAC 12.1 + lipopolysaccharide (LPS) + Montanide adjuvant with vaccination #1 * Group 1c: MELITAC 12.1 + lipopolysaccharide (LPS) adjuvant + Montanide adjuvant with all vaccinations | Biological | Cohort 1 |
| MELITAC 12.1 + Montanide ISA-51 + polyICLCCohort 2 will be divided into three sub-groups and will receive: * Group 2a: MELITAC 12.1 + polyICLC adjuvant * Group 2b: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with vaccination #1 * Group 2c: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with all vaccinations | Biological | Cohort 2 |
Primary outcome
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
8 secondary outcomes
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
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 12 Aug 2016.
- Derived from this study: PubMed 32350119Pollack KE, Meneveau MO, Melssen MM, Lynch KT, Koeppel AF, Young SJ, Turner S, Kumar P, Sol-Church K, Mauldin IS, Slingluff CL Jr. Incomplete Freund's adjuvant reduces arginase and enhances Th1 dominance, TLR signaling and CD40 ligand expression in the vaccine site microenvironment. J Immunother Cancer. 2020 Apr;8(1):e000544. doi: 10.1136/jitc-2020-000544.
- Derived from this study: PubMed 31248461Melssen MM, Petroni GR, Chianese-Bullock KA, Wages NA, Grosh WW, Varhegyi N, Smolkin ME, Smith KT, Galeassi NV, Deacon DH, Gaughan EM, Slingluff CL Jr. A multipeptide vaccine plus toll-like receptor agonists LPS or polyICLC in combination with incomplete Freund's adjuvant in melanoma patients. J Immunother Cancer. 2019 Jun 27;7(1):163. doi: 10.1186/s40425-019-0625-x.
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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.
Craig L Slingluff, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS) and MELITAC 12.1 + Montanide ISA-51 + polyICLC in people with Melanoma, run by Craig L Slingluff, Jr 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 24 inclusion and 26 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 12 Aug 2016. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety, with measures of adverse events, locally and systemically (time frame: over 6 months). The study lists 2 primary outcomes in all. 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 NCT01585350, 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 12 Aug 2016.