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Cancer Vaccine +/− CDX-1127 for Melanoma (Mel-65 Trial)
Mel-65 Trial Summary
This trial is testing a new cancer vaccine with two different adjuvants to see if it is safe and if it boosts the immune response to the vaccine.
Mel-65 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMel-65 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 • NCT02515227Mel-65 Trial Design
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Who is running the clinical trial?
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- You have received certain medications or treatments within a specific time period before joining the study, such as chemotherapy or radiation therapy.You have received treatment with CDX-1127 or a similar type of medication before.You may have had different types of melanoma, but it needs to be confirmed by a specific type of examination. If you have cutaneous melanoma, it will be staged using a specific system.You have allergies to any part of the vaccine.You have a known addiction to alcohol or drugs and are currently using them, or have used illicit IV drugs in the past year.You have a history of serious autoimmune disorders that required strong medication to treat.You are in good enough physical condition to perform daily activities without help or with a little help.You have received the 6MHP vaccine before.You have been diagnosed with advanced stage melanoma within the last 6 months.You have HIV or active Hepatitis C.Your diabetes is not well managed, with an HgbA1c level higher than 8.5%.You weigh less than 110 pounds because a lot of blood will need to be drawn for the study.You have had lung inflammation caused by an autoimmune condition before.People with small, uncertain findings on their scans or during their check-ups may be allowed to participate.If you have stage IIA melanoma as determined by the DecisionDx Melanoma test, you may be eligible.You have severe heart disease classified as Class III or IV by the New York Heart Association.
- Group 1: Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127
- Group 2: Arm B: 6MHP/Montanide ISA-51 + polyICLC
- 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 individuals can join this clinical trial?
"Yes, the information on clinicaltrials.gov concurs that this study is currently recruiting patients. The study was first posted on November 13th 2018 and last updated April 28th 2022. This trial needs 30 more patients from 2 different centres."
What are the desired outcomes of this research?
"The purpose of this study is to assess the immunogenicity of the 6MHP vaccine over a 30-day period. Secondary outcomes include the frequency of circulating CD4+ Th1 responses and CD4+ Th1 memory responses, as well as the impact of CDX-1127 on regulatory T cells."
Have other medical studies like this been conducted in the past?
"There are 7 ongoing studies involving 6MHP in 50 different cities spread across 2 countries. The first study was completed in 2017 and, since then, 8 trials have been completed."
Are patients still being recruited for this research study?
"The clinical trial is currently seeking patients, with 30 needed from 2 sites. The first posting was on 11/13/2018, with the most recent edit on 4/28/2022."
Are there any other scientific papers which mention 6MHP?
"Currently, there are 7 concurrent trials studying 6MHP. Unfortunately, none of these live studies have reached Phase 3 yet. The majority of the trial locations for 6MHP are situated in Hays, Kansas; however, there are a total of 72 centres running these experiments."
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