MelanomaPhase 1MEL53NCT01264731
Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma
A Phase 1 study testing MELITAC 12.1 and Imiquimod in people with Melanoma, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of the study is to determine 1) the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine… 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 and Imiquimod
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2012
- 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
- Participants with stage IIIB, IIIC or IV melanoma with cutaneous metastases.
- Patients must have adequate cutaneous metastases of melanoma readily accessible for biopsy to provide a minimum of 0.3 cm3 of tissue per biopsy (approximately 0.85 cm by 0.85 cm x 0.85 cm or five 2mm core biopsies) at each of three time points. Several scenarios may fulfill the tumor burden requirement. For example, a patient may have one large lesion from which core biopsies can be taken for the first and second biopsy time points and then the entire lesion excised for the final tissue sample. Other combinations are acceptable.
- The intent is to limit this study to patients with cutaneous melanoma metastasis rather than subcutaneous or lymph node metastasis because imiquimod may not penetrate to those deeper metastases.
- Patients may have had multiple primary melanomas.
- Patients may have had or may have a metastasis from a cutaneous primary site, mucosal primary site, ocular primary site, or unknown primary site.
- Patients who have had brain metastases may be eligible if they meet the following criteria
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- Patients with less than or equal to 5 metastases may be eligible as long as the following 3 criteria are true:
- 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 metastasis greater than 2 cm at the time of protocol entry
- Patients with greater than 5 metastases may be eligible if the above 3 criteria are met and if at least one year has elapsed since the last treatment.
- All participants must have ECOG performance status of 0 or 1 and ability and willingness to give informed consent
- Patients must have at least one intact axillary and/or inguinal lymph node basin. A patient with a prior lymph node biopsy may be a candidate if lymphoscintigraphy demonstrates intact drainage to a node in that basin. A lymphoscintigram may be performed during screening to ensure that there is drainage to a regional node from a planned vaccine site. If the lymphoscintigram is performed and a sentinel lymph node is not located, the patient will be ineligible for this study if no other vaccine sites are available.
- Laboratory parameters as follows: The following laboratory parameters will be required for all participants. If a lab value appears to be an error or a result of a transient or treatable condition, the investigator will use his/her clinical judgment to decide if the test may be repeated. The requirements for inclusion are as follows:
- HLA-A1, -A2, -A3, or -A11+
- ANC > 1000/mm3
- Platelets > 100,000/mm3
- Hgb ≥ 9 g/dL
- HGBA1C < 7%
- 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 (within 6 months of study entry)
- Hepatitis C negative (within 6 months of study entry)
- LDH up to 2 x ULN
- Patients must be 18 years or older at study entry
Who cannot join
- Patients who have had brain metastases unless they meet the criteria outlined above
- 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 will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation. Examples for such circumstances may include untreated bone metastases at risk for fracture, and rapidly progressive low volume disease.
- 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 pharmacologic growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
- Interferon therapy.
- Interleukin-2 or other interleukins.
- Topical 5% Imiquimod cream: Patients must not have had imiquimod therapy to any body site within 4 weeks of study entry and must not have had any prior imiquimod therapy to the lesions to be treated, watched or biopsied on this present study. If imiquimod has been used in the past and either led to complete regression of the treated lesions, or those lesions have been removed surgically, then the patient may be eligible.
- Prior melanoma vaccinations may be an exclusion criterion in som 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 (including MELITAC 12.1 and similar vaccines) or with non-peptide vaccines.
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Women must also not be breast feeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
- 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 according to the New York Heart Association classification as having Class III or IV heart disease (Appendix 4).
- Patients with a body weight < 110 lbs because of the amount and frequency with which blood will be drawn
- Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. 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
The purpose of the study is to determine 1) the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.
Read the detailed description
Primary goals:
Safety:
- To determine the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma.
Biologic effect:
- To evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.
Secondary goals:
- To assess whether T cells infiltrating melanoma metastases after imiquimod, with and without vaccination, are reactive to peptides in the vaccine.
- To evaluate whether topical imiquimod decreases the proportion of FoxP3+ CD25hi CD4+ cells (putative regulatory T cells, Tregs) among tumor infiltrating T cells.
- To estimate the effects of vaccine on CXCR3, CLA, and activation marker expression by circulating and tumor-infiltrating antigen-experienced CD4 and CD8 T cells.
- To obtain preliminary data on the clinical response of cutaneous metastases of melanoma to the proposed combination regimen.
- To determine the expression of TLR7 by immune cells and/or melanoma cells in the metastatic melanoma microenvironment.
- To obtain preliminary data on associations between metastatic melanoma T cell infiltration patterns (immunotypes) and molecular and clinical responses to imiquimod.
Design:
The present proposal is for a clinical trial and associated correlative studies that bring together several observations and unmet scientific and clinical needs that have promise for a new effective immunotherapy for melanoma metastases. This is an open-label two-cohort, nonrandomized, pilot study of a combination of topical imiquimod plus systemic vaccination with MELITAC 12.1 vaccine, an emulsion of a mixture of 12 class I MHC-restricted melanoma peptides (12-MP) and a class II MHC-restricted tetanus toxoid helper peptide (tet). Cohort 1 will receive the combination of imiquimod + vaccine; Cohort 2 will receive imiquimod only. Patients will be eligible for cohort 1 if they are eligible for the vaccine based on HLA type and clinical factors. Cohort 2 is for patients who are not eligible for the vaccine.
Primary Endpoints:
Safety:
- Toxicity profile of topical imiquimod at sites of melanoma, with or without MELITAC 12.1 vaccine.
Biologic effect:
- Change in levels of intratumoral E-selectin and infiltrating TCD4 and TCD8 lymphocytes:
- pretreatment vs after vaccine + imiquimod;
- with vaccine vs. without vaccine (cohorts 1 vs 2);
- lesions with imiquimod vs. without imiquimod.
Secondary Endpoints:
The following will be evaluated by comparing pretreatment to after vaccine + imiquimod, and comparing findings from patients with and without vaccine (cohorts 1 and 2), as well as lesions with and without imiquimod.
- Change in the number of vaccine-reactive T cells in the melanoma metastases, as determined by ELIspot and tetramer analyses.
- Change in the percentage of FoxP3+ CD25hi CD4+ (putative regulatory T cells, Tregs) among tumor infiltrating T cells as determined by immunohistochemistry and flow cytometry.
- Expression of CXCR3, CLA, and activation markers (CD69, CD137, HLA-DR, CD27 and CD28) on vaccine-reactive cells in the blood and within the melanoma metastases by immunohistochemistry and flow cytometric analyses.
- TLR7 expression by cells in the metastatic melanoma microenvironment.
- Changes in T cell infiltration patterns of metastases (immunotype) The following will be evaluated post-treatment
- Clinical regression of individual imiquimod-treated and untreated metastases
- Conditions
- Melanoma
- Being tested
- MELITAC 12.1, Imiquimod
- Keywords
- melanoma, peptide vaccine, aldara, imiquimod, 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 12.1Biological
Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, and 15. During cycle two, three vaccines will be administered over a 9-week period on days 36, 57, 78. Participants in cohort 1 will receive MELITAC 12.1 (100 mcg each of the12-MP and 200 mcg of Peptide-tet) administered subcutaneously (1 ml) and intradermally (1 ml) in Montanide ISA-51 VG adjuvant at a single vaccination site.
ImiquimodDrug
Also called Aldara
Topical Imiquimod regimen: Beginning on day 1, patients in cohorts 1 and 2 will have one or more cutaneous melanoma metastases treated topically with 5% imiquimod cream, with a dose of 1 to 3 packets of imiquimod daily, (depending on the extent of cutaneous metastases). Each packet contains 250 mg of cream and may be used for a surface area of up to 20 cm2. The number of lesions that are treated will be dependent on the availability and size of the lesions. In addition, if available, at least two lesions will be followed without treatment with the plan that they will be excised at week 3 (day 22) and week 6 (day 43), respectively, as controls. Imiquimod will be applied daily for seven days each week for 12 weeks. One course of treatment will be three weeks in duration, with evaluation by a clinician after every treatment course.
| Study group | Role | What they receive |
|---|---|---|
| peptide vaccine plus imiquimod | Active comparator | Peptide Vaccine: Days 1, 8, 15, 36, 57, 78 Imiquimod: Applied daily on days 1-85. Receives: Biological: MELITAC 12.1; Drug: Imiquimod |
| Imiquimod | Active comparator | Imiquimod: Applied daily on days 1-85. Receives: Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To determine the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma.
Measured: 6 months
Secondary outcomes (1)
Biologic: To evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L Slingluff, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264731
- Sponsor's protocol ID
- 15168
- Acronym
- MEL53
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2010
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tran CA, Lynch KT, Meneveau MO, Katyal P, Olson WC, Slingluff CL Jr. Intratumoral IFN-gamma or topical TLR7 agonist promotes infiltration of melanoma metastases by T lymphocytes expanded in the blood after cancer vaccine. J Immunother Cancer. 2023 Feb;11(2):e005952. doi: 10.1136/jitc-2022-005952.
PubMed 36746511
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma
- ClinicalTrials.gov ID
- NCT01264731
- Acronym / sponsor ID
- MEL53 / 15168
- Conditions
- Melanoma
- Keywords
- melanoma, peptide vaccine, aldara, imiquimod, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Dec 2010 (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 the study is to determine 1) the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.
Detailed description
Primary goals:
Safety:
- To determine the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma.
Biologic effect:
- To evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.
Secondary goals:
- To assess whether T cells infiltrating melanoma metastases after imiquimod, with and without vaccination, are reactive to peptides in the vaccine.
- To evaluate whether topical imiquimod decreases the proportion of FoxP3+ CD25hi CD4+ cells (putative regulatory T cells, Tregs) among tumor infiltrating T cells.
- To estimate the effects of vaccine on CXCR3, CLA, and activation marker expression by circulating and tumor-infiltrating antigen-experienced CD4 and CD8 T cells.
- To obtain preliminary data on the clinical response of cutaneous metastases of melanoma to the proposed combination regimen.
- To determine the expression of TLR7 by immune cells and/or melanoma cells in the metastatic melanoma microenvironment.
- To obtain preliminary data on associations between metastatic melanoma T cell infiltration patterns (immunotypes) and molecular and clinical responses to imiquimod.
Design:
The present proposal is for a clinical trial and associated correlative studies that bring together several observations and unmet scientific and clinical needs that have promise for a new effective immunotherapy for melanoma metastases. This is an open-label two-cohort, nonrandomized, pilot study of a combination of topical imiquimod plus systemic vaccination with MELITAC 12.1 vaccine, an emulsion of a mixture of 12 class I MHC-restricted melanoma peptides (12-MP) and a class II MHC-restricted tetanus toxoid helper peptide (tet). Cohort 1 will receive the combination of imiquimod + vaccine; Cohort 2 will receive imiquimod only. Patients will be eligible for cohort 1 if they are eligible for the vaccine based on HLA type and clinical factors. Cohort 2 is for patients who are not eligible for the vaccine.
Primary Endpoints:
Safety:
- Toxicity profile of topical imiquimod at sites of melanoma, with or without MELITAC 12.1 vaccine.
Biologic effect:
- Change in levels of intratumoral E-selectin and infiltrating TCD4 and TCD8 lymphocytes:
- pretreatment vs after vaccine + imiquimod;
- with vaccine vs. without vaccine (cohorts 1 vs 2);
- lesions with imiquimod vs. without imiquimod.
Secondary Endpoints:
The following will be evaluated by comparing pretreatment to after vaccine + imiquimod, and comparing findings from patients with and without vaccine (cohorts 1 and 2), as well as lesions with and without imiquimod.
- Change in the number of vaccine-reactive T cells in the melanoma metastases, as determined by ELIspot and tetramer analyses.
- Change in the percentage of FoxP3+ CD25hi CD4+ (putative regulatory T cells, Tregs) among tumor infiltrating T cells as determined by immunohistochemistry and flow cytometry.
- Expression of CXCR3, CLA, and activation markers (CD69, CD137, HLA-DR, CD27 and CD28) on vaccine-reactive cells in the blood and within the melanoma metastases by immunohistochemistry and flow cytometric analyses.
- TLR7 expression by cells in the metastatic melanoma microenvironment.
- Changes in T cell infiltration patterns of metastases (immunotype) The following will be evaluated post-treatment
- Clinical regression of individual imiquimod-treated and untreated metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peptide vaccine plus imiquimod | Active comparator | Biological: MELITAC 12.1, Drug: ImiquimodPeptide Vaccine: Days 1, 8, 15, 36, 57, 78 Imiquimod: Applied daily on days 1-85. |
| Imiquimod | Active comparator | Drug: ImiquimodImiquimod: Applied daily on days 1-85. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Participants with stage IIIB, IIIC or IV melanoma with cutaneous metastases.
- Patients must have adequate cutaneous metastases of melanoma readily accessible for biopsy to provide a minimum of 0.3 cm3 of tissue per biopsy (approximately 0.85 cm by 0.85 cm x 0.85 cm or five 2mm core biopsies) at each of three time points. Several scenarios may fulfill the tumor burden requirement. For example, a patient may have one large lesion from which core biopsies can be taken for the first and second biopsy time points and then the entire lesion excised for the final tissue sample. Other combinations are acceptable.
- The intent is to limit this study to patients with cutaneous melanoma metastasis rather than subcutaneous or lymph node metastasis because imiquimod may not penetrate to those deeper metastases.
- Patients may have had multiple primary melanomas.
- Patients may have had or may have a metastasis from a cutaneous primary site, mucosal primary site, ocular primary site, or unknown primary site.
Key exclusion criteria (24 listed)
- Patients who have had brain metastases unless they meet the criteria outlined above
- 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 will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation. Examples for such circumstances may include untreated bone metastases at risk for fracture, and rapidly progressive low volume disease.
- 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 12.1Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, and 15. During cycle two, three vaccines will be administered over a 9-week period on days 36, 57, 78. Participants in cohort 1 will receive MELITAC 12.1 (100 mcg each of the12-MP and 200 mcg of Peptide-tet) administered subcutaneously (1 ml) and intradermally (1 ml) in Montanide ISA-51 VG adjuvant at a single vaccination site. | Biological | peptide vaccine plus imiquimod |
| ImiquimodAlso: AldaraTopical Imiquimod regimen: Beginning on day 1, patients in cohorts 1 and 2 will have one or more cutaneous melanoma metastases treated topically with 5% imiquimod cream, with a dose of 1 to 3 packets of imiquimod daily, (depending on the extent of cutaneous metastases). Each packet contains 250 mg of cream and may be used for a surface area of up to 20 cm2. The number of lesions that are treated will be dependent on the availability and size of the lesions. In addition, if available, at least two lesions will be followed without treatment with the plan that they will be excised at week 3 (day 22) and week 6 (day 43), respectively, as controls. Imiquimod will be applied daily for seven days each week for 12 weeks. One course of treatment will be three weeks in duration, with evaluation by a clinician after every treatment course. | Drug | Imiquimod, peptide vaccine plus imiquimod |
Primary outcome
Safety: To determine the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma.
Time frame: 6 months
1 secondary outcome
Biologic: To evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.
Time frame: 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 16 Dec 2016.
- Derived from this study: PubMed 36746511Tran CA, Lynch KT, Meneveau MO, Katyal P, Olson WC, Slingluff CL Jr. Intratumoral IFN-gamma or topical TLR7 agonist promotes infiltration of melanoma metastases by T lymphocytes expanded in the blood after cancer vaccine. J Immunother Cancer. 2023 Feb;11(2):e005952. doi: 10.1136/jitc-2022-005952.
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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, M.D. 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 and Imiquimod in people with Melanoma, run by University of Virginia 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 27 inclusion and 24 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 16 Dec 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: To determine the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma. (time frame: 6 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 NCT01264731, which also lists 1 linked publication.
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 16 Dec 2016.