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Kinase Inhibitor

Encorafenib + Binimetinib Before Surgery for Melanoma

Phase 2
Waitlist Available
Led By Leslie A Fecher
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patient must be able to take oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with stage IIIB-D melanoma that has spread to lymph nodes and have a BRAF V600 mutation. They must be able to take oral meds, lie still for PET/CT scans, use contraception if of childbearing potential, and not have distant metastases or other serious health issues. HIV-positive patients can join if their condition is stable.Check my eligibility
What is being tested?
The effectiveness of Encorafenib and Binimetinib before surgery in treating melanoma with lymph node involvement is being tested. The study also evaluates how well an imaging agent (18F-FLT) used in PET/CT scans predicts the response to these drugs.See study design
What are the potential side effects?
Potential side effects include risk of heart problems, bleeding events, liver function changes, high blood pressure, fatigue, skin rash or disorders, vision changes like retinal vein occlusion (RVO), muscle pain or weakness due to elevated creatine kinase (CK).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can take pills by mouth.
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I am using or willing to use effective birth control or abstain from sex during and after the study.
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My scans show measurable cancer, taken within the last 4 weeks.
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My melanoma is stage III B/C/D and can be seen or felt.
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My melanoma can be entirely removed by surgery, as confirmed by a specialist.
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I am medically cleared for surgery.
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I am currently taking blood thinners.
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I have at least one visible lymph node metastasis, but not in the N1c category.
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My cancer has a BRAF V600 mutation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fluorothymidine F-18 (18F-FLT) positron emission tomography (PET)/computed tomography (CT) uptake
Pathologic complete response (pCR) rate
Secondary outcome measures
Change in 18F-FLT PET/CT uptake
Change in CD8 positive (+) tumor infiltrating lymphocytes
Change in CD8+ T cell infiltration in tumor or tumor bed
+7 more
Other outcome measures
Change in Ki-67 status in tumor or tumor bed

Side effects data

From 2022 Phase 3 trial • 702 Patients • NCT02928224
78%
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%
Asthenia
16%
Oedema peripheral
16%
Stomatitis
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%
Pollakiuria
11%
Trichiasis
11%
Vitreous floaters
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Infusion related reaction
8%
Iron deficiency
8%
Visual impairment
8%
Macular oedema
8%
Weight decreased
8%
Hypertrichosis
8%
Flank pain
8%
Hypokalaemia
8%
Nasopharyngitis
8%
Rhinitis allergic
8%
Proteinuria
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Pleural effusion
5%
Anal haemorrhage
5%
Abdominal pain lower
5%
Chorioretinopathy
5%
Infection
5%
Trichomegaly
5%
Musculoskeletal pain
5%
Bone pain
5%
Nail disorder
5%
Hypophosphataemia
5%
Pruritus generalised
5%
Urinary incontinence
5%
Hypocalcaemia
5%
Musculoskeletal chest pain
5%
Wound
5%
Ascites
5%
Colitis
5%
Nervous system disorder
5%
Restless legs syndrome
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%
Rectal haemorrhage
5%
Erythema
5%
Retinal detachment
5%
Pulmonary embolism
5%
Dysphonia
5%
Haematuria
5%
Blood creatinine increased
5%
Depression
5%
Palpitations
3%
Alopecia
3%
Hyperkeratosis
3%
Skin papilloma
3%
Back pain
3%
Confusional state
3%
Kidney infection
3%
Epistaxis
3%
Streptococcal infection
3%
Urinary tract infection bacterial
3%
Device occlusion
3%
Large intestinal ulcer
3%
Urinary tract obstruction
3%
Upper respiratory tract infection
3%
Cholangitis
3%
Melanocytic naevus
3%
Bacterial sepsis
3%
Large intestinal ulcer hemorrhage
3%
Rectal hemorrhage
3%
Tumour pain
3%
Rhabdomyolysis
3%
Colon cancer
3%
Sepsis
3%
Acute kidney injury
3%
Large intestine ulcer
3%
Neutropenia
3%
Large intestine perforation
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 (18F-FLT, PET/CT, encorafenib, binimetinib, surgery)Experimental Treatment6 Interventions
NEOADJUVANT TREATMENT: Patients receive 18F-FLT IV and undergo a PET/CT scan approximately 60 minutes later. Within 2 weeks, patients receive encorafenib PO QD and binimetinib PO BID on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive 18F-FLT IV and undergo a second PET/CT scan approximately 60 minutes later. SURGICAL RESECTION: Within 2 weeks of completing therapy with encorafenib and binimetinib, patients undergo surgery. ADJUVANT TREATMENT: Within 2-7 days after surgery, patients resume treatment with encorafenib PO QD and binimetinib PO BID on days 1-28. Treatment repeats every 28 days for up to 11 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Computed Tomography
2017
Completed Phase 2
~2790
Conventional Surgery
2006
Completed Phase 3
~1080
Encorafenib
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
115 Previous Clinical Trials
176,819 Total Patients Enrolled
9 Trials studying Melanoma
3,531 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,643 Total Patients Enrolled
557 Trials studying Melanoma
193,230 Patients Enrolled for Melanoma
Leslie A FecherPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04221438 — Phase 2
Melanoma Research Study Groups: Treatment (18F-FLT, PET/CT, encorafenib, binimetinib, surgery)
Melanoma Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04221438 — Phase 2
Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04221438 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Feb 2025