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Cancer Vaccine
Peptide Vaccine + Dabrafenib + Trametinib for Melanoma (Mel61 Trial)
Phase < 1
Waitlist Available
Led By Elizabeth Gaughan, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after the last vaccination with 6mhp
Awards & highlights
Mel61 Trial Summary
This trial will see if it's safe to give a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy, as well as if the combo affects the immune system. Blood and tumor tests will be done to monitor effects.
Mel61 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after the last vaccination with 6mhp
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after the last vaccination with 6mhp
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse event profile for the combination of BRAFi, MEKi, and 6MHP
CD4+ T cell responses in the blood
Secondary outcome measures
An evaluation of the infiltration of T cells into melanoma metastases pre and post-vaccination.
Antibody responses against 6MHP
Mel61 Trial Design
1Treatment groups
Experimental Treatment
Group I: 6MHP and MEKi and BRAFiExperimental Treatment3 Interventions
The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 36, 57, 78. All peptide vaccines are administered intradermally and subcutaneously.
A selective BRAF inhibitor and a selective MEK inhibitor will be administered in accordance with the prescribing information.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
6MHP
2016
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,659 Total Patients Enrolled
557 Trials studying Melanoma
193,225 Patients Enrolled for Melanoma
Craig L Slingluff, JrLead Sponsor
23 Previous Clinical Trials
738 Total Patients Enrolled
18 Trials studying Melanoma
633 Patients Enrolled for Melanoma
Elizabeth Gaughan, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Melanoma
3 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced melanoma that can be measured and confirmed through clinical or radiological tests. This includes different types of melanoma and will be staged according to specific medical guidelines.You have melanoma that can be completely removed with surgery, even if it's not easily measured by specific criteria.If you have had brain metastases, you can join the study if: the tumors were removed by surgery or treated with radiosurgery or immunotherapy, there has been no growth in the tumors for at least 4 weeks, the tumors are not too large, your neurological symptoms have improved without using steroids for at least 7 days, and you have an ECOG performance status of 0-2.Your blood counts and liver function tests must be within a certain range, and you must have specific lymph nodes in your body.You have taken medicines targeting mutated BRAF in the past, but only if they helped you and it's been at least 6 months since you stopped taking them.If you are in cohorts 1 & 2 and have advanced melanoma, you must agree to have a biopsy before starting treatment and on day 22. The biopsy will be taken from accessible areas like lymph nodes, skin, or liver using a needle or surgical procedure.You have had surgery to remove melanoma, and there is no sign of the disease. You must start treatment within 12 weeks of your last surgery or within 12 weeks of being declared free of disease by other treatments. If you had a specific type of therapy for a tumor and have no other signs of the disease, you can join this part of the study.Criterion: You cannot have received certain medications or treatments within the past few weeks, have specific health conditions, be pregnant or breastfeeding, have certain heart or diabetes conditions, have certain autoimmune disorders, have certain cancer diagnoses, have addiction to alcohol or drugs, have a low body weight, or have a specific enzyme deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: 6MHP and MEKi and BRAFi
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.
Is the recruitment phase of this experiment still in progress?
"Clinicaltrials.gov currently indicates that this clinical trial is actively seeking participants. The first listing of the study was posted on April 1st 2016, with its most recent update being made June 23rd 2022."
Answered by AI
Are there any other exploratory investigations utilizing Trametinib?
"At the moment, 95 trials examining Trametinib's efficacy and safety are in progress with 6 of them being at Phase 3. Although most trials take place in Omaha, Nebraska there also exists a plethora of medical institutions conducting such experiments across 5807 locations."
Answered by AI
How many participants are being enrolled for this clinical trial?
"Affirmative. The information found on clinicaltrials.gov confirms that this study is actively searching for participants, with 27 needed from 2 sites since it was first posted in April 2016 and last updated June 23rd 2022."
Answered by AI
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