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Cancer Vaccine
Melanoma Vaccine for Melanoma (Mel66 Trial)
Phase 1 & 2
Waitlist Available
Led By Craig Slingluff
Research Sponsored by Craig L Slingluff, Jr
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No brain metastasis is > 2 cm in diameter at the time of registration.
- Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 85 and/or day 176
Awards & highlights
Mel66 Trial Summary
This trial will test a new cancer vaccine made of 6MHP and a mutated neoantigen peptide combined with two different adjuvants. The vaccine will be given to people with advanced melanoma to see if it is safe and if it can create an immune response against the cancer.
Who is the study for?
This trial is for adults over 18 with melanoma, including uveal (eye) melanoma, who are clinically free of disease after treatment within the past 6 months. They must have good organ function and performance status, not be pregnant or breastfeeding, agree to contraception use if applicable, and weigh more than 110 pounds. Exclusions include HIV or active Hepatitis C infection, autoimmune disorders requiring therapy, recent live vaccines or checkpoint blockade therapy.Check my eligibility
What is being tested?
The study tests a peptide vaccine combining 6MHP and mutated BRAF neoantigen with adjuvants CDX-1140 (CD40 antibody) and PolyICLC (TLR3 agonist). It aims to assess safety and immune response effects by analyzing participants' blood and skin tissue in the lab.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to vaccine components, inflammation from adjuvant activation of the immune system which could lead to symptoms like fever or fatigue. Specific side effect profiles will be monitored closely throughout the trial.
Mel66 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any brain tumors larger than 2 cm.
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My brain cancer was either fully removed by surgery or treated with targeted radiation.
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I have at least one intact lymph node in my armpit or groin area.
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I am fully active or can carry out light work.
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My neurological symptoms from brain metastases are back to normal.
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I have at least one lymph node area that has not been surgically removed.
Mel66 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 85 and/or day 176
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85 and/or day 176
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunogenicity: Estimate immune response rate to a melanoma vaccine combined with CDX-1140
Safety of CDX-1140 + melanoma peptide vaccine (6MHP and NeoAg-mBRAF) + PolyICLC
Secondary outcome measures
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on CD4+ Th1 memory response to vaccine antigens
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on circulating regulatory T cells
Immunogenicity: Impact of addition of CDX-1140 to melanoma vaccine on induction of CD4+ Th1 responses to vaccine antigens
+1 moreSide effects data
From 2020 Phase 1 & 2 trial • 22 Patients • NCT02515227100%
Injection site reaction
83%
Skin induration
67%
Fatigue
50%
Fever
50%
Pruritis
50%
Rash maculo-papular
33%
Arthralgia
33%
Myalgia
33%
Lymphocyte count decreased
33%
Bruising
17%
Anemia
17%
Chills
17%
Flu-like symptoms
17%
Aspartate aminotransferase increased
17%
Hyperuricemia
17%
Headache
17%
Allergic rhinitis
17%
Dyspnea
17%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
6MHP + Pembrolizumab (PD-1 Antibody-naive Cohort)
6MHP + Pembrolizumab (PD-1 Antibody-experienced Cohort)
Mel66 Trial Design
1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
6MHP
2016
Completed Phase 2
~100
PolyICLC
2014
Completed Phase 2
~50
CDX-1140
2017
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
Celldex TherapeuticsIndustry Sponsor
61 Previous Clinical Trials
3,928 Total Patients Enrolled
8 Trials studying Melanoma
447 Patients Enrolled for Melanoma
Craig L Slingluff, JrLead Sponsor
23 Previous Clinical Trials
724 Total Patients Enrolled
18 Trials studying Melanoma
619 Patients Enrolled for Melanoma
Craig SlingluffPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
28 Total Patients Enrolled
2 Trials studying Melanoma
28 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken nitrosoureas within the last 6 weeks.I may have small, unclear findings on my scans but can still join.I had uveal melanoma but am now free of it due to treatment or surgery within the last 6 months.My melanoma was stage IB with ulceration, II, III, or IV at diagnosis or recurrence but now I'm clinically free of disease.I have 4-10 large moles on my torso or limbs that can be biopsied.I haven't had chemotherapy, radiation, or specific medications in the last 4 weeks.I have not received a live vaccine in the last 30 days.I have received immunotherapy within the last 3 months.My melanoma diagnosis was confirmed through a tissue or cell test.My body weight is less than 110 pounds.You need to have X-ray or other imaging tests to make sure there are no signs of melanoma spreading in your body.You have a known addiction to alcohol or drugs and are currently using them, or have recently used illegal drugs.I do not have any brain tumors larger than 2 cm.I had uveal melanoma but have been disease-free for 6 months due to treatment or surgery.I may have small, unclear findings on my scans but can still join.My melanoma was stage IB-II-III-IV and I am now clinically free of disease after treatment within the last 6 months.I have had brain metastases but meet certain conditions.I have an autoimmune disorder treated with strong medication.I had brain metastases but meet specific health criteria.My brain cancer was either fully removed by surgery or treated with targeted radiation.I have at least one intact lymph node in my armpit or groin area.You have HIV or have an active Hepatitis C infection.My melanoma originated from the skin, eye, mucous membranes, or the primary source is unknown.I am fully active or can carry out light work.I am 18 years old or older.My melanoma originated from the skin, eye, mucous membranes, or the primary source is unknown.My neurological symptoms from brain metastases are back to normal.My organ functions are within normal ranges according to recent tests.My heart condition is severe, classified as Class III or IV.I currently have or had pneumonitis in the last 30 days.I have 4-10 large moles on my body that can be easily accessed for biopsy.I have at least one lymph node area that has not been surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: All Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are eligible to participate in this research project?
"That is correct. The listing on clinicaltrials.gov suggests that the trial is ongoing and looking for 22 patients at 2 sites. The first posting was on 9/28/2020, with the most recent edit taking place on 8/25/2022."
Answered by AI
Are there any open positions remaining in this trial for new patients?
"Yes, this trial is currently looking for participants, as reflected in the most recent update on clinicaltrials.gov (8/25/2022). The initial posting was on 9/28/2020."
Answered by AI
What benefits does this clinical trial hope to bring patients?
"The primary goal of this study, which will be observed on or around day 127 and/or 176, is to gauge the safety of CDX-1140 in combination with a melanoma peptide vaccine (6MHP and NeoAg-mBRAF) + PolyICLC. Additionally, researchers will secondary outcomes including but not limited to the immunogenicity of the CDX-1140 addition to the vaccine's effectiveness in inducing CD4+ Th1 responses as well as the number of participants with circulating Tregs (CD4+ FoxP3+) in proportion to circulating CD4 T cells."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Michigan
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am interested in adjuvant therapy for uveal melanoma. I had plaque brachytherapy on July 27, 2023.
PatientReceived 2+ prior treatments
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