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Peptide Vaccine + Dabrafenib + Trametinib for Melanoma (Mel61 Trial)
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Mel61 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: 6MHP and MEKi and BRAFi
- 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
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."
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."
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."
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