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Kinase Inhibitor
BRAF-MEK Inhibitor Therapy for Melanoma
Phase < 1
Recruiting
Led By Zeynep Eroglu, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600E mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical Laboratory Improvement Act (CLIA) certified laboratory, meeting one of the following American Joint Committee on Cancer (AJCC) (8th edition) staging criteria: AJCC stage IV, AJCC stage IIIC or IIID with unresectable nodal/locoregional involvement
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN (in participants with liver metastases =< 5 x ULN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will enroll BRAF mutant patients with an elevated baseline LDH who have not previously been treated with a BRAF or MEK inhibitor.
Who is the study for?
Adults with advanced BRAF mutant melanoma (stage IIIC-IV) who have measurable disease, good organ function, and an ECOG performance status of ≤2. They must not be pregnant or nursing, agree to use non-hormonal contraception for 6 months post-treatment, and haven't had certain prior treatments like BRAF/MEK inhibitors in the metastatic setting.Check my eligibility
What is being tested?
The trial is testing a combination of encorafenib and binimetinib—drugs that block enzymes promoting tumor growth—with nivolumab, which may help the immune system fight cancer. The goal is to see if this trio can effectively kill more melanoma cells.See study design
What are the potential side effects?
Potential side effects include liver enzyme elevation due to encorafenib and binimetinib; fatigue, digestive issues from all three drugs; skin reactions from targeted therapy; and possible immune-related complications such as inflammation in organs from nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma cannot be surgically removed and has a specific BRAF mutation.
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My liver function tests are within the required range.
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I haven't had severe side effects from nivolumab that needed long-term steroids.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
8 Week Completion Rate
Secondary outcome measures
Objective Tumor Response Rate
Time to Treatment Failure
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: BRAF-MEK Inhibitor TherapyExperimental Treatment3 Interventions
Participants will receive 450 mg Encorafenib daily, along with 45 mg Binimetinib twice daily and 240 mg Nivolumab IV every 2 weeks.
Group II: Arm BActive Control1 Intervention
Participants will receive 240 mg Nivolumab IV every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
2021
Completed Phase 3
~960
Binimetinib
2018
Completed Phase 3
~1100
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,482 Total Patients Enrolled
Zeynep Eroglu, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a certain amount of a specific type of DNA in your blood when you start the study.I will use non-hormonal birth control during and for 6 months after treatment.Your creatinine level is less than or equal to 2 times the upper limit of normal at the study site.I have had cancer before, but it's under control and I'm not currently on cancer treatment.I do not have any serious ongoing illnesses and my heart is classified as class 2B or better.I have HIV, am on effective treatment, and my last viral load was undetectable.I have brain metastases but they are stable and I'm not on steroids.My liver function tests are within the required range.I haven't had severe side effects from nivolumab that needed long-term steroids.I haven't had anti-PD-1/PD-L1 or BRAF/MEK therapy for advanced cancer, but it's okay if it was over 24 weeks ago for early-stage treatment.You have enough infection-fighting white blood cells in your body.My melanoma cannot be surgically removed and has a specific BRAF mutation.I am currently pregnant, nursing, or planning to become pregnant.Your hemoglobin level is at least 8.0 grams per deciliter.Your total bilirubin levels should be within a certain range, unless you have a condition called Gilbert's syndrome.I have been treated with BRAF/MEK inhibitors or anti-PD-1/PD-L1 therapy for advanced cancer.I can take care of myself but might not be able to do heavy physical work.I am not pregnant or cannot become pregnant.You must have a way for doctors to measure your disease using specific guidelines.I am 18 years old or older.Your platelet count is at least 75,000 per microliter.I am taking methotrexate or less than 10 mg of prednisone daily.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: BRAF-MEK Inhibitor Therapy
- Group 2: Arm B
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.
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