MelanomaPhase 2MEL39NCT00938223
Evaluation of the Immunogenicity of Vaccination With Multiple Synthetic Melanoma Peptides With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With Advanced Melanoma
A Phase 2 study testing 4-peptide and 12-peptide melanoma vaccines in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
This is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB versus III versus IV). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Melanoma
- What is being tested?
- 4-peptide and 12-peptide melanoma vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Nov 2003
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed, by cytologic or histologic examination, with resected AJCC stage IIB, stage III, or stage IV cutaneous or mucosal melanoma.
- Patients who have had brain metastases will be eligible if (a) they have been resected surgically, or (b) there have been 1-3 brain metastases less than or equal to 2 cm that have been treated with the gamma-knife or stereotactic radiosurgery. Surgical resections or gamma-knife must have been completed no greater than 10 months prior to study entry.
- Tumor must express either gp100 (for patients HLA-A2+ or HLA-A3+) or tyrosinase (for patients HLA-A1+ or HLA-A2+) by immunohistochemistry. The tumor deposit(s) to be examined will be the primary lesion for stage IIB patients, or the most recently resected metastatic disease in stage III or stage IV patients. If the most recently resected deposit is not available than material from prior resected tumor will be evaluated.
- Patients who refuse treatment with IFN-alpha despite being candidates for IFN-alpha.
- Patients who are not eligible for treatment with IFN-alpha for the following reasons:
- active ischemic heart disease or cerebro-vascular disease,
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- anginal syndrome requiring ongoing medications, or history of myocardial infarction, or arrhythmia disorder,
- history of treatment for depression or active depression, or other psychiatric disorder,
- patients with autoimmune disorders who are not excluded based on criteria listed in section 5.2.8 of the present study,
- patients in whom greater than 6 months have elapsed since their definitive surgical therapy,
- hypersensitivity to IFN-alpha or any component associated with the treatment,
- debilitating medical conditions such as severe pulmonary disease or severe diabetes mellitus,
- patients with thyroid abnormalities whose thyroid function cannot be maintained in the normal range without medication
- patients with resected stage IV disease provided they meet the eligibility criteria for the proposed study,
- patients who discontinue IFN-alpha therapy due to the occurrence of a major toxicity that has been documented by their treating physician,
- patients who have undergone IFN-alpha therapy and have experienced tumor progression while on IFN or after completing IFN.
- All patients must have:
- Karnofsky performance of 80% or higher,
- ECOG performance status of 0 or 1,
- Ability and willingness to give informed consent.
- Laboratory parameters as follows:
- HLA-A1, -A2, or -A3 (+),
- ANC > 1000/mm3, and Platelets > 100,000 and Hgb > 9,
- Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN), Bilirubin up to 2.5 x ULN, Alkaline phosphatase up to 2.5 x ULN,
- Renal: Creatinine up to 1.5 x ULN,
- Serology: HIV negative and Hepatitis C negative within 6 months of study entry,
- LDH up to 1.5 x ULN.
- Age 18 years or older at the time of study entry.
Who cannot join
- Patients with ocular melanoma.
- Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 4 weeks.
- Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- 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), Allergy desensitization injections, Corticosteroids, administered parenterally or orally. Topical corticosteroids are acceptable. Any growth factors, Interleukin-2 or other interleukins.
- Prior melanoma vaccinations will be an exclusion criteria. However, those patients who have recurred either after or during administration of a melanoma vaccine will be eligible to enroll 12 weeks following their last vaccination.
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- Patients may not have been vaccinated previously with any of the peptides that are included in this protocol. Other investigational drugs or investigational therapy will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis.
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of childbearing 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. 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.
- Patients who have systemic autoimmune disease with visceral involvement.
- Patients who have another cancer diagnosis, except that the following diagnoses will be allowed: squamous cell cancer of the skin without known metastasis, basal cell cancer of the skin without known metastasis, carcinoma in situ of the breast (DCIS or LCIS), carcinoma in situ of the cervix, any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years.
- Patients with known addiction to alcohol or drugs who is actively taking those agents, or patients with recent (within 1 year) or ongoing illicit IV drug use.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: This is an Open-label, Phase II Study of a Vaccine Comprising Melanoma Peptides and a Tetanus Helper Peptide, Administered in GM-CSF-in-adjuvant. Patients Will be Randomized to Receive One of Two Different Vaccine Regimens. Patients Will be Stratified by Stage of Disease (IIB vs. III vs. IV).
This is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB versus III versus IV).
Read the detailed description
Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B.
Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.
Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.
All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN).
- Conditions
- Melanoma
- Being tested
- 4-peptide and 12-peptide melanoma vaccines
- Keywords
- melanoma, peptide, vaccine, adjuvant, advanced
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-peptide and 12-peptide melanoma vaccinesBiological
Also called MELITAC 4.1, MELITAC 12.1
Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B.
Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.
Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.
All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN).
| Study group | Role | What they receive |
|---|---|---|
| 4-peptide vaccine | Active comparator | Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A 2) and a tetanus helper peptide. Receives: Biological: 4-peptide and 12-peptide melanoma vaccines |
| 12-peptide vaccine | Active comparator | Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide. Receives: Biological: 4-peptide and 12-peptide melanoma vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the 12-peptide mixture and cumulative number of T cells derived from the sentinel immunized node that are reactive to the 12 melanoma peptides included in the vaccine, in the context of HLA-A1, -A2, or -A3.
Measured: 24 months
Secondary outcomes (2)
Immunogenicity of the individual peptides incorporated into the vaccine, cytotoxic and proliferative responses of T-cells to autologous and allogeneic melanoma cells.
Measured: Week 4
Disease-free survival of stage IIB and stage III patients
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startAug 2000
- Primary completionNov 2003
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938223
- Sponsor's protocol ID
- 8878
- Acronym
- MEL39
- Status last verified
- Apr 2018
- First submitted
- 24 Jun 2009
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ninmer EK, Zhu H, Chianese-Bullock KA, Slingluff CL Jr. Twenty-year survival outcomes after multipeptide vaccination for resected high-risk melanoma: A post-hoc analysis of a randomized clinical trial. Int J Cancer. 2025 Nov 1;157(9):1912-1923. doi: 10.1002/ijc.70006. Epub 2025 Jun 19.
PubMed 40536492
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is an Open-label, Phase II Study of a Vaccine Comprising Melanoma Peptides and a Tetanus Helper Peptide, Administered in GM-CSF-in-adjuvant. Patients Will be Randomized to Receive One of Two Different Vaccine Regimens. Patients Will be Stratified by Stage of Disease (IIB vs. III vs. IV).
- ClinicalTrials.gov ID
- NCT00938223
- Acronym / sponsor ID
- MEL39 / 8878
- Conditions
- Melanoma
- Keywords
- melanoma, peptide, vaccine, adjuvant, advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Nov 2003 (actual)
- First posted
- 13 Jul 2009 (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 is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB versus III versus IV).
Detailed description
Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B.
Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.
Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.
All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-peptide vaccine | Active comparator | Biological: 4-peptide and 12-peptide melanoma vaccinesGroup A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A 2) and a tetanus helper peptide. |
| 12-peptide vaccine | Active comparator | Biological: 4-peptide and 12-peptide melanoma vaccinesGroup B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients who have been diagnosed, by cytologic or histologic examination, with resected AJCC stage IIB, stage III, or stage IV cutaneous or mucosal melanoma.
- Patients who have had brain metastases will be eligible if (a) they have been resected surgically, or (b) there have been 1-3 brain metastases less than or equal to 2 cm that have been treated with the gamma-knife or stereotactic radiosurgery. Surgical resections or gamma-knife must have been completed no greater than 10 months prior to study entry.
- Tumor must express either gp100 (for patients HLA-A2+ or HLA-A3+) or tyrosinase (for patients HLA-A1+ or HLA-A2+) by immunohistochemistry. The tumor deposit(s) to be examined will be the primary lesion for stage IIB patients, or the most recently resected metastatic disease in stage III or stage IV patients. If the most recently resected deposit is not available than material from prior resected tumor will be evaluated.
- Patients who refuse treatment with IFN-alpha despite being candidates for IFN-alpha.
- Patients who are not eligible for treatment with IFN-alpha for the following reasons:
Key exclusion criteria (13 listed)
- Patients with ocular melanoma.
- Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 4 weeks.
- Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- 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), Allergy desensitization injections, Corticosteroids, administered parenterally or orally. Topical corticosteroids are acceptable. Any growth factors, Interleukin-2 or other interleukins.
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 |
|---|---|---|
| 4-peptide and 12-peptide melanoma vaccinesAlso: MELITAC 4.1, MELITAC 12.1Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B. Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide. Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide. All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN). | Biological | 12-peptide vaccine, 4-peptide vaccine |
Primary outcome
Safety of the 12-peptide mixture and cumulative number of T cells derived from the sentinel immunized node that are reactive to the 12 melanoma peptides included in the vaccine, in the context of HLA-A1, -A2, or -A3.
Time frame: 24 months
2 secondary outcomes
Immunogenicity of the individual peptides incorporated into the vaccine, cytotoxic and proliferative responses of T-cells to autologous and allogeneic melanoma cells.
Time frame: Week 4
Disease-free survival of stage IIB and stage III patients
Time frame: ongoing
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 2 May 2018.
- Derived from this study: PubMed 40536492Ninmer EK, Zhu H, Chianese-Bullock KA, Slingluff CL Jr. Twenty-year survival outcomes after multipeptide vaccination for resected high-risk melanoma: A post-hoc analysis of a randomized clinical trial. Int J Cancer. 2025 Nov 1;157(9):1912-1923. doi: 10.1002/ijc.70006. Epub 2025 Jun 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4-peptide and 12-peptide melanoma vaccines 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 28 inclusion and 13 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 2 May 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 of the 12-peptide mixture and cumulative number of T cells derived from the sentinel immunized node that are reactive to the 12 melanoma peptides included in the vaccine, in the context of HLA-A1, -A2, or -A3. (time frame: 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 NCT00938223, 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 2 May 2018.