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Kinase Inhibitor
Binimetinib + Encorafenib for Melanoma
Phase 2
Recruiting
Led By Isabella C Glitza
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years at the time of informed consent
Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistochemistry [IHC]) at any time prior to Screening or during Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests whether binimetinib and encorafenib can help control melanoma that has spread to the brain.
Who is the study for?
Adults with metastatic melanoma that has spread to the brain, including those who have previously received FDA-approved BRAF inhibitors. Participants must have a specific BRAFV600 mutation and be in good enough health as determined by certain lab parameters. Pregnant or breastfeeding individuals are excluded, as well as those with significant heart conditions, infections, gastrointestinal impairments, or a history of certain blood clots.Check my eligibility
What is being tested?
The trial is testing binimetinib and encorafenib's effectiveness on melanoma that has reached the central nervous system. These drugs aim to halt tumor growth by inhibiting key enzymes. The study includes patients who've had prior treatments and those new to these medications.See study design
What are the potential side effects?
Potential side effects may include fatigue, skin reactions, vision changes due to eye problems like retinal vein occlusion (RVO), liver enzyme elevations indicating potential liver damage, muscle pain or weakness from neuromuscular issues, high blood pressure, bleeding events and clotting disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My tumor has the BRAFV600 mutation.
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Your blood tests need to show specific levels for things like white blood cells, hemoglobin, and platelets. Your liver and kidney function also need to be within certain limits. If you can become pregnant, you need to have a negative pregnancy test and agree to use birth control during the study. You also need to be able to keep up with your doctor visits and treatment plan.
Select...
I have brain metastases but no leptomeningeal disease.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have a brain tumor between 0.5 and 3 cm that is getting worse.
Select...
My cancer has spread to the lining of my brain or spinal cord, confirmed by scans or tests.
Select...
My diagnosis of melanoma is confirmed through tissue examination.
Select...
I am taking 4 mg or less of dexamethasone daily for LMD, or just enough for adrenal insufficiency.
Select...
I have melanoma with a BRAF V600 mutation and it has spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Incidence of dose interruptions, dose modifications and discontinuations due to AEs
Incidence of dose-limiting toxicities (DLTs)
+1 moreSecondary outcome measures
Disease control rate
Duration of response (DOR)
Extracranial response rate
+3 moreSide effects data
From 2022 Phase 3 trial • 702 Patients • NCT0292822478%
Diarrhoea
68%
Dermatitis acneiform
59%
Nausea
54%
Fatigue
51%
Vomiting
51%
Dry Skin
43%
Pyrexia
43%
Anaemia
41%
Decreased appetite
38%
Abdominal pain
38%
Constipation
35%
Dyspnoea
32%
Vision blurred
30%
Blood creatine increased
30%
Blood creatine phosphokinase increased
24%
Arthralgia
24%
Myalgia
24%
Skin fissures
22%
Back Pain
22%
Dizziness
19%
Malaise
19%
Urinary tract infection
19%
Headache
19%
Aspartate aminotransferase increased
16%
Stomatitis
16%
Asthenia
16%
Oedema peripheral
16%
PPE syndrome
16%
Hypomagnesaemia
16%
Rash maculo-papular
16%
Palmar-planar erythrodysaesthesia
16%
Chills
16%
Paronychia
16%
Rash pustular
16%
Alanine aminotransferase increased
16%
Dysgeusia
16%
Peripheral sensory neuropathy
14%
Cough
14%
Abdominal pain upper
14%
Infusion-related reaction
14%
Ejection fraction decreased
14%
Dry eye
11%
Trichiasis
11%
Vitreous floaters
11%
Pollakiuria
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Hypokalaemia
8%
Weight decreased
8%
Macular oedema
8%
Proteinuria
8%
Rhinitis allergic
8%
Infusion related reaction
8%
Iron deficiency
8%
Nasopharyngitis
8%
Hypertrichosis
8%
Visual impairment
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Pleural effusion
5%
Rectal haemorrhage
5%
Hypophosphataemia
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Bone pain
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Hypocalcaemia
5%
Nervous system disorder
5%
Ascites
5%
Abdominal pain lower
5%
Nail disorder
5%
Colitis
5%
Urinary incontinence
5%
Infection
5%
Wound
5%
Anal haemorrhage
5%
Insomnia
5%
Gastroesophageal reflux disease
5%
Abdominal distension
5%
Eczema
5%
Cystitis
5%
Renal failure
5%
Conjunctivitis
5%
Syncope
5%
Dehydration
5%
Dry Mouth
5%
Skin hyperpigmentation
5%
Muscle spasms
5%
Erythema
5%
Retinal detachment
5%
Pulmonary embolism
5%
Dysphonia
5%
Haematuria
5%
Blood creatinine increased
5%
Depression
5%
Palpitations
3%
Bacterial sepsis
3%
Device occlusion
3%
Large intestine perforation
3%
Large intestinal ulcer hemorrhage
3%
Confusional state
3%
Back pain
3%
Kidney infection
3%
Large intestinal ulcer
3%
Skin papilloma
3%
Upper respiratory tract infection
3%
Tumour pain
3%
Streptococcal infection
3%
Melanocytic naevus
3%
Cholangitis
3%
Alopecia
3%
Urinary tract infection bacterial
3%
Rhabdomyolysis
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Urinary tract obstruction
3%
Epistaxis
3%
Colon cancer
3%
Sepsis
3%
Acute kidney injury
3%
Large intestine ulcer
3%
Neutropenia
3%
Bacteria sepsis
3%
Hydronephrosis
3%
Neuropathy peripheral
3%
Abdominal abscess
3%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combined Safety Lead-in
Phase 3: Triplet Arm
Phase 3: Doublet Arm
Phase 3: Control Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (encorafenib, binimetinib)Experimental Treatment3 Interventions
Patients receive encorafenib PO QD and binimetinib PO BID on day 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,311 Total Patients Enrolled
102 Trials studying Melanoma
25,279 Patients Enrolled for Melanoma
Isabella C GlitzaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
76 Total Patients Enrolled
2 Trials studying Melanoma
76 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have previously received immunotherapy or participated in a clinical trial.I haven't had an active infection in the last week.My tumor has the BRAFV600 mutation.I have BRAF V600 mutant melanoma with brain metastases and haven't been treated with BRAF/MEK inhibitors.I haven't had any other cancer treatments recently.I have brain metastases but no leptomeningeal disease.I can take care of myself but might not be able to do heavy physical work.I have had brain or spine radiation but still have new or worsening brain lesions.Your blood tests need to show specific levels for things like white blood cells, hemoglobin, and platelets. Your liver and kidney function also need to be within certain limits. If you can become pregnant, you need to have a negative pregnancy test and agree to use birth control during the study. You also need to be able to keep up with your doctor visits and treatment plan.I do not have significant heart issues, recent serious heart events, uncontrolled heart rhythm problems, severe eye conditions, recent major blood clots, certain infections like active hepatitis B or C, and I am not pregnant or planning to become pregnant during the study.You have tested positive for HIV or have been diagnosed with AIDS, even if you are being treated for it.I have a brain tumor between 0.5 and 3 cm that is getting worse.My cancer has spread to the lining of my brain or spinal cord, confirmed by scans or tests.I am taking a low dose of steroids for brain metastases and my symptoms have been stable for a week.I have previously been treated with FDA-approved BRAF inhibitors for my condition.It has been at least 14 days since my last dose of medication or treatment.My diagnosis of melanoma is confirmed through tissue examination.I am taking steroids for brain-related symptoms.I am taking 4 mg or less of dexamethasone daily for LMD, or just enough for adrenal insufficiency.You cannot swallow and keep down the study medication.I have leptomeningeal disease.I have previously received immunotherapy or participated in a clinical trial.I have melanoma with a BRAF V600 mutation and it has spread to my brain.I haven't had any live virus vaccines in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (encorafenib, binimetinib)
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.
Have researchers tried this treatment before on people?
"Encorafenib has been researched since 2012 when the first clinical trial was conducted by Pfizer. There are currently 64 active trials for Encorafenib in 41 countries and 1240 cities."
Answered by AI
Are there any vacancies in this particular clinical trial for testing new medication?
"From what is available on clinicaltrials.gov, it seems as though this study is still enrolling patients. The original posting date was December 27th 2021 and the most recent update was on August 22nd of this year."
Answered by AI
Has Encorafenib been cleared by the FDA?
"Encorafenib's safety is based on data from Phase 2 trials, which means that while there is evidence indicating it is safe, there is none suggesting it effective. Our team at Power gave it a score of 2."
Answered by AI
What other medical studies have included Encorafenib as a treatment?
"Encorafenib is being trialed in 64 different clinical studies. Of these, 4 are large Phase 3 trials. Many of the small studies for Encorafenib's efficacy are based out of Orange City, Florida; however, there are 3478 research sites total for this medication."
Answered by AI
Encorafenib is most often used to treat what type of condition?
"Encorafenib is a treatment option for patients with the BRAF V600K mutation, metastatic melanoma, and unresectable melanoma."
Answered by AI
How many people can sign up for this clinical trial at most?
"That is correct. The information available on clinicaltrials.gov demonstrates that this study, which was first advertised on December 27th 2021, is still looking for patients to participate. This trial needs 35 individuals from 1 location."
Answered by AI
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