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Encorafenib + Binimetinib Before Surgery for Melanoma
Study Summary
This trial is studying a combination of two drugs, encorafenib and binimetinib, to see how well they work before surgery in treating patients with melanoma that has spread to the lymph nodes and has a BRAF V600 mutation. 18F-FLT PET/CT scans may be used to predict how well the melanoma will respond to the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT02928224Trial Design
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Who is running the clinical trial?
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- I am fully active or restricted in physically strenuous activity but can do light work.I can take pills by mouth.I haven't had a stroke or blood clot in the last 3 months.I do not have a muscle disorder that increases my CK levels.I am using or willing to use effective birth control or abstain from sex during and after the study.My cancer has not spread to distant parts of my body.I have not had any other type of cancer.My scans show measurable cancer, taken within the last 4 weeks.I haven't taken any medication, including herbal ones, or supplements in the last week.If you have HIV, you can still join the study if your viral load is undetectable and your CD4 count is stable and high.I do not have an infection that needs treatment with IV antibiotics.My melanoma is stage III B/C/D and can be seen or felt.My melanoma can be entirely removed by surgery, as confirmed by a specialist.I am medically cleared for surgery.I have no history or current signs of retinal vein occlusion.I have never had pancreatitis.My heart is healthy and I don't have significant heart disease.I am currently taking blood thinners.I have not had radiation on the area where my disease can be measured.My digestive system works well enough to absorb medication properly.I do not have active hepatitis B or C.I have at least one visible lymph node metastasis, but not in the N1c category.You need to be able to stay still during the PET/CT scan for the whole imaging study.Your blood tests must show specific levels for white blood cells, red blood cells, blood clotting factors, liver enzymes, and kidney function.I have never been treated with BRAF or MEK inhibitors.My cancer has a BRAF V600 mutation.I am not pregnant or breastfeeding.I am not allergic to binimetinib or encorafenib.I haven't had adjuvant therapy for my current cancer, but it's been over 6 months since my last immune therapy.
- Group 1: Treatment (18F-FLT, PET/CT, encorafenib, binimetinib, surgery)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
What is the cap on recruitment for this experiment?
"That is accurate. According to the information on clinicaltrials.gov, this study has not yet reached its full quota of 42 patients across 4 different locations."
Is there still room for new participants in this clinical trial?
"This study, which was first brought to the public's attention on February 18th 2020 according to clinicaltrials.gov, is currently looking for more patients."
Does this research represent a new frontier for treatments?
"Since 2012, when the first study on Encorafenib was funded by Pfizer, this medication has been researched in a total of 64 clinical trials. These studies are live across 1240 cities and 41 countries."
Are there any negative side effects associated with Encorafenib?
"Encorafenib's safety is supported by some data, but its efficacy has not been corroborated yet. Therefore, it received a score of 2."
What medical conditions has Encorafenib been shown to improve?
"Encorafenib can be used to treat patients with metastatic melanoma, unresectable braf v600k mutation, and other difficult-to-treat melanomas."
Are there any other ongoing research projects that use Encorafenib?
"Azienda Ospedaliera Universitaria Federico II first studied encorafenib in 2012. To date, a total of 90 clinical trials have been completed with 64 more currently underway. Many of these live trials are based in Los Angeles, CA."
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