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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)
Must not have
Female subjects who are pregnant, intend to become pregnant or are nursing
Patients previously treated with BRAF/MEK inhibitor or anti-PD-1/PD-L1 therapy in the metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant, nursing, or planning to become pregnant.
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I have been treated with BRAF/MEK inhibitors or anti-PD-1/PD-L1 therapy for advanced cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
8 Week Completion Rate
Secondary study objectives
Objective Tumor Response Rate
Time to Treatment Failure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2022
Completed Phase 3
~970
Binimetinib
2018
Completed Phase 3
~1250
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,816 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

Encorafenib; Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03543969 — Phase < 1
Skin Cancer Research Study Groups: Arm A: BRAF-MEK Inhibitor Therapy, Arm B
Skin Cancer Clinical Trial 2023: Encorafenib; Binimetinib Highlights & Side Effects. Trial Name: NCT03543969 — Phase < 1
Encorafenib; Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03543969 — Phase < 1
~2 spots leftby Nov 2025
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