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Melanoma Vaccine for Melanoma (Mel66 Trial)
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.
Mel66 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMel66 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 & 2 trial • 22 Patients • NCT02515227Mel66 Trial Design
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- 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.
- Group 1: All Participants
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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