MelanomaPhase 1/2Mel66NCT04364230
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)
A Phase 1/2 study testing 6MHP, NeoAg-mBRAF and PolyICLC in people with Melanoma and Ocular Melanoma, run by Craig L Slingluff, Jr at 2 sites in United States.
Trial summary
This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Ocular Melanoma, Uveal Melanoma
- What is being tested?
- 6MHP, NeoAg-mBRAF and PolyICLC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2020to 14 Mar 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- a. For individuals with primary cutaneous, mucosal, or unknown melanoma, an individual must have stage IB ulcerated, II, III, or IV melanoma at original diagnosis or at restaging after recurrence, and be rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
- For patients with stage II, III, or IV uveal melanoma, patients must be rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
- An individual with small radiologic or clinical findings of an indeterminate nature may still be eligible
- An individual may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma.
- Biopsies of nevi are optional. Participants with at least 4-10 evaluable nevi at least 4 mm in diameter that are located on truncal or non-acral extremity sites and are accessible for biopsy and observation will be asked to participate in the optional nevi biopsies
- Diagnosis of melanoma must be confirmed by cytological or histological examination except that patients with clinically localized primary uveal melanoma will not require pathologic review.
- Individuals will be required to have radiological studies to rule out radiologically evident melanoma metastasis.
- Individuals who have had brain metastases will be eligible if all of the following are true:
- Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery.
- No brain metastasis is > 2 cm in diameter at the time of registration.
- Any neurologic symptoms attributable to brain metastases have returned to baseline.
- There is no evidence of new or enlarging brain metastases.
- The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed ≥ 1 week and ≤ 6 months prior to registration.
- ECOG performance status of 0 or 1 (Section 13.3).
- Ability and willingness to give informed consent.
- Adequate organ function as determined by laboratory parameters.
- Male or female, age 18 years or older at registration.
- Individuals must have at least one intact (undissected) axillary and/or inguinal lymph node basin.
- For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 3 months after receiving the last dose of study drug.
Main Exclusion Criteria:
- Individuals who have received the following medications or treatments at any time within 4 weeks of registration:
- Chemotherapy
- Interferon (e.g. Intron-A®)
- Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
- Allergy desensitization injections
- High doses of systemic corticosteroids, with some qualifications and exceptions
- Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
- Interleukins (e.g. Proleukin®)
- Any investigational medication
- Targeted therapies specific for mutated BRAF or for MEK
- Individuals who are currently receiving nitrosoureas or who have received this therapy within 6 weeks of registration.
- Individuals who are currently receiving a checkpoint molecule blockade therapy, or who have received this therapy within 12 weeks of registration.
- Individuals with known or suspected allergies to any component of the vaccine.
- Individuals who have received prior melanoma vaccinations with 6MHP plus the mutated BRAF peptide. However, participants who have received prior vaccinations will be eligible to enroll 12 weeks following their last vaccination if they have recurred during or after administration of the vaccine, and if their vaccines did not include all of the synthetic peptides included in this protocol.
- Individuals who have previously received CDX-1140 or another CD40 agonistic antibody.
- Pregnancy. Female individuals of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration.
- HIV positivity or evidence of active Hepatitis C virus (testing to be done within 6 months of study entry).
- Female individuals must not be breastfeeding.
- Individuals in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
- Individuals classified according to the New York Heart Association classification as having Class III or IV heart disease (Section 13.4).
- Individuals must not have had prior autoimmune disorders requiring systemic cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. Some autoimmune disorders will not be exclusionary:
- The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring non-steroidal anti-inflammatory drugs (NSAID) medications
- Resolved childhood asthma/atopy
- Endocrinopathies on stable hormone replacement therapy
- Individuals with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use.
- Individuals with current pneumonitis. Individuals must not have had pneumonitis within 30 days of registration. Patients who have had complete resolution of prior pneumonitis will be eligible.
- Individuals who have received a live vaccine within 30 days of registration.
- Body weight < 110 pounds (50 kg) at registration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Enhanced Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists in Patients With Melanoma
This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). The study will also investigate the effects of the vaccine and the adjuvants on the immune response. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and skin tissue.
- Conditions
- Melanoma, Ocular Melanoma, Uveal Melanoma
- Being tested
- 6MHP, NeoAg-mBRAF, PolyICLC, CDX-1140
- Keywords
- peptide, vaccine, 6MHP, adjuvant, polyICLC, CDX-1140, NeoAg-mBRAF, CD40, TLR, nevi, nevus, BRAF585-614-V600E, Ocular Melanoma, Uveal Melanoma
- Medical subject headings
- Melanoma, Uveal Melanoma, Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MHPDrug
Also called 6 melanoma helper peptide vaccine
6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
NeoAg-mBRAFDrug
Also called BRAF 585-614 (V600E)
BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E).
PolyICLCDrug
polyICLC, local adjuvant
CDX-1140Drug
CDX-1140, local adjuvant
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | 6MHP (200mcg of each peptide) and 300mcg of NeoAg-mBRAF will be co-administered locally with 0.9mg of polyICLC and CDX-1140. There will be a dose escalation of CDX-1140 (50mcg, 200mcg, 800mcg, 3.0mg). A vaccine containing all of these components will be given on days 1, 22, 43, and 64. The vaccine will be given subcutaneously/intradermally. Receives: Drug: 6MHP; Drug: NeoAg-mBRAF; Drug: PolyICLC; Drug: CDX-1140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CDX-1140 + melanoma peptide vaccine (6MHP and NeoAg-mBRAF) + PolyICLC
Number of participants with dose-limiting toxicities based on CTCAE v5.0
Measured: 30 days after receiving the last dose of study drug
Immunogenicity: Estimate immune response rate to a melanoma vaccine combined with CDX-1140
Number of participants with durable or persistent CD4+ Th1 responses to the melanoma vaccine at either day 85 or day 176, or both
Measured: Day 85 and/or Day 176
Secondary outcomes (4)
Immunogenicity: Impact of vaccine containing peptides plus CDX-1140 and polyICLC on regulatory T cells
Number of FoxP3+ CD4+ T cells per mm^2 in vaccine site biopsies
Measured: Day 50
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on circulating regulatory T cells
Number of participants with circulating Tregs (CD4+ FoxP3+) as a proportion of circulating CD4 T cells
Measured: Through Day 85
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on induction of CD4+ Th1 responses to vaccine antigens
Number of participants with CD4+ T cell response; maximum increase after vaccination at any time point.
Measured: Through Day 176
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on CD4+ Th1 memory response to vaccine antigens
Number of participants with CD4+ T cell response to the melanoma peptides
Measured: Day 176
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start28 Sep 2020
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- Celldex Therapeutics
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L. Slingluff, Jr., MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364230
- Sponsor's protocol ID
- HSR200006
- Acronym
- Mel66
- Status last verified
- Jul 2024
- First submitted
- 21 Apr 2020
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ninmer EK, Petroni GR, Gastman BR, Gaughan EM, Isaacs JM, Haden K, Kaur V, Wages NA, Chianese-Bullock KA, Smith KT, Wright P, Bryant J, Dunlap-Brown M, Engel JA, Bekiranov S, Mauldin IS, Truong TG, Bullock TNJ, Slingluff CL Jr. Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). J Immunother Cancer. 2026 Mar 3;14(3):e013613. doi: 10.1136/jitc-2025-013613.
PubMed 41775435
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists in Patients With Melanoma
- ClinicalTrials.gov ID
- NCT04364230
- Acronym / sponsor ID
- Mel66 / HSR200006
- Conditions
- Melanoma, Ocular Melanoma, Uveal Melanoma
- Keywords
- peptide, vaccine, 6MHP, adjuvant, polyICLC, CDX-1140, NeoAg-mBRAF, CD40
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- Celldex Therapeutics
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 28 Apr 2020 (actual)
- 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 study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). The study will also investigate the effects of the vaccine and the adjuvants on the immune response. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and skin tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: 6MHP, Drug: NeoAg-mBRAF, Drug: PolyICLC, Drug: CDX-11406MHP (200mcg of each peptide) and 300mcg of NeoAg-mBRAF will be co-administered locally with 0.9mg of polyICLC and CDX-1140. There will be a dose escalation of CDX-1140 (50mcg, 200mcg, 800mcg, 3.0mg). A vaccine containing all of these components will be given on days 1, 22, 43, and 64. The vaccine will be given subcutaneously/intradermally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 6MHPAlso: 6 melanoma helper peptide vaccine6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides | Drug | All Participants |
| NeoAg-mBRAFAlso: BRAF 585-614 (V600E)BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E). | Drug | All Participants |
| PolyICLCpolyICLC, local adjuvant | Drug | All Participants |
| CDX-1140CDX-1140, local adjuvant | Drug | All Participants |
Primary outcome
Safety of CDX-1140 + melanoma peptide vaccine (6MHP and NeoAg-mBRAF) + PolyICLC
Time frame: 30 days after receiving the last dose of study drug
Number of participants with dose-limiting toxicities based on CTCAE v5.0
Immunogenicity: Estimate immune response rate to a melanoma vaccine combined with CDX-1140
Time frame: Day 85 and/or Day 176
Number of participants with durable or persistent CD4+ Th1 responses to the melanoma vaccine at either day 85 or day 176, or both
4 secondary outcomes
Immunogenicity: Impact of vaccine containing peptides plus CDX-1140 and polyICLC on regulatory T cells
Time frame: Day 50
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on circulating regulatory T cells
Time frame: Through Day 85
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on induction of CD4+ Th1 responses to vaccine antigens
Time frame: Through Day 176
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on CD4+ Th1 memory response to vaccine antigens
Time frame: Day 176
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 Jul 2024.
- Derived from this study: PubMed 41775435Ninmer EK, Petroni GR, Gastman BR, Gaughan EM, Isaacs JM, Haden K, Kaur V, Wages NA, Chianese-Bullock KA, Smith KT, Wright P, Bryant J, Dunlap-Brown M, Engel JA, Bekiranov S, Mauldin IS, Truong TG, Bullock TNJ, Slingluff CL Jr. Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). J Immunother Cancer. 2026 Mar 3;14(3):e013613. doi: 10.1136/jitc-2025-013613.
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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, Jr., MD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 6MHP, NeoAg-mBRAF and PolyICLC in people with Melanoma and Ocular Melanoma, run by Craig L Slingluff, Jr at 2 sites 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?
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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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 CDX-1140 + melanoma peptide vaccine (6MHP and NeoAg-mBRAF) + PolyICLC (time frame: 30 days after receiving the last dose of study drug). 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 NCT04364230, 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 Jul 2024.