Actively Recruiting
Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
35
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies the effects of binimetinib and encorafenib in treating patients with melanoma that has spread to the central nervous system (metastases). Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may help control melanoma that has spread to the brain.
CONDITIONS
Official Title
Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Age 18 years or older at the time of consent
- Histologically confirmed melanoma diagnosis
- Presence of BRAFV600 mutation in tumor tissue confirmed by local assay
- For Cohort A: BRAF V600 mutant melanoma patients with progressive CNS metastases including brain metastases and/or leptomeningeal disease (LMD)
- For Cohort A: Prior therapy with FDA-approved BRAF inhibitors with or without MEK inhibitors required; no washout period needed
- For Cohort A: Prior immunotherapy or investigational agent allowed with 14-day washout since last dose
- For Cohort B: BRAF V600 mutant melanoma patients with CNS metastases who are treatment naive to BRAF/MEK inhibitors; prior immunotherapy allowed
- For patients with parenchymal brain metastases without LMD: at least one progressing brain lesion 0.5 to 3 cm measurable by MRI
- For patients with LMD: radiographic or CSF cytological evidence of LMD
- Eastern Cooperative Oncology Group performance status 0 to 2
- Patients may use steroids to control CNS symptoms with dosing limits and stability requirements
- Prior radiation therapy allowed under specific conditions and washout periods
- Concurrent anti-cancer systemic therapies not allowed
- Appropriate laboratory values for blood counts, liver and kidney function
- Female patients of childbearing potential must have negative pregnancy test and agree to contraception
- Male patients must agree to use contraception
- Ability and willingness to comply with study visits and procedures
You will not qualify if you...
- Active infection within 7 days before starting study drug, except viral infections related to tumor
- Use of live virus vaccines within 30 days before study drug; dead virus vaccines allowed
- Inability to swallow or retain study treatment
- Known HIV/AIDS diagnosis
- Significant cardiovascular disease including recent acute coronary syndrome, heart failure, low heart ejection fraction, significant arrhythmias, or prolonged QT interval
- Neuromuscular disorders such as inflammatory myopathies or muscular dystrophy
- Gastrointestinal disorders affecting drug absorption or history of pancreatitis
- History or risk factors for retinal vein occlusion or retinal degenerative disease
- Use of strong or moderate CYP3A4/5 inhibitors or inducers within 1 week before study treatment
- Thromboembolic events within 12 weeks before study treatment except stable catheter-related thrombosis
- Evidence of active hepatitis B or C infection unless cleared or vaccinated
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Other severe medical or psychiatric conditions that increase risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Isabella C Glitza, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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