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Kinase Inhibitor

Binimetinib + Imatinib for Melanoma

Phase 2
Recruiting
Led By Katy Tsai, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HBV viral load undetectable on suppressive therapy, if indicated
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Must not have
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
Impairment of gastrointestinal function or disease affecting absorption of study drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery.

Who is the study for?
This trial is for adults with unresectable Stage III-IV KIT-mutant melanoma. Participants must have measurable disease progression after standard therapy or be unable to tolerate it, and have good organ function. HIV-positive individuals on effective therapy can join, as well as those with treated/cured hepatitis C or controlled hepatitis B. Pregnant or breastfeeding women cannot participate, and sexually active participants must use contraception.
What is being tested?
The study tests binimetinib and imatinib's effectiveness in treating advanced KIT-mutant melanoma by blocking enzymes that promote tumor cell growth. This phase II trial aims to determine if this combination treatment can help manage the disease in patients who cannot undergo surgery.
What are the potential side effects?
Potential side effects of binimetinib and imatinib may include fatigue, nausea, diarrhea, muscle pain, skin rash, eye problems like blurred vision or retinal vein occlusion (RVO), heart issues such as irregular heartbeat or heart failure, liver function changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hepatitis B virus load is undetectable with treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My melanoma diagnosis was confirmed through lab tests.
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My melanoma cannot be surgically removed and is in an advanced stage.
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I am HIV-positive, on treatment, and my viral load is undetectable.
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My melanoma has a KIT mutation, confirmed by a certified test.
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I had hepatitis C but am cured or currently being treated with no detectable virus.
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I do not have any other cancer that could affect the treatment's safety or results.
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I don't need immediate brain or spinal cord treatment for cancer spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or am at risk for blocked veins in my eye.
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I have a digestive condition that affects how I absorb medication.
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I cannot swallow or keep down the medication.
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I have heart problems or significant heart disease.
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I am taking medication that cannot be stopped safely before starting the study treatment.
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I have a muscle disorder that causes high CK levels.
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I am not currently on any experimental drugs and haven't been for the last 14 days or 5 half-lives of the drug.
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I cannot switch from warfarin to another blood thinner safely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Objective response rate (ORR)
Secondary study objectives
Clinical benefit rate (CBR)
Median duration of response
Overall survival (OS)
+2 more

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%
Stomatitis
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%
Pollakiuria
11%
Vitreous floaters
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Rhinitis allergic
8%
Infusion related reaction
8%
Hypokalaemia
8%
Visual impairment
8%
Macular oedema
8%
Hypertrichosis
8%
Iron deficiency
8%
Nasopharyngitis
8%
Weight decreased
8%
Flank pain
8%
Proteinuria
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Trichomegaly
5%
Wound
5%
Pleural effusion
5%
Restless legs syndrome
5%
Musculoskeletal pain
5%
Nervous system disorder
5%
Infection
5%
Hypocalcaemia
5%
Hypophosphataemia
5%
Rectal haemorrhage
5%
Anal haemorrhage
5%
Ascites
5%
Colitis
5%
Abdominal pain lower
5%
Nail disorder
5%
Pruritus generalised
5%
Bone pain
5%
Musculoskeletal chest pain
5%
Chorioretinopathy
5%
Urinary incontinence
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%
Tumour pain
3%
Large intestinal ulcer hemorrhage
3%
Rectal hemorrhage
3%
Melanocytic naevus
3%
Large intestinal ulcer
3%
Skin papilloma
3%
Upper respiratory tract infection
3%
Urinary tract infection bacterial
3%
Kidney infection
3%
Epistaxis
3%
Hyperkeratosis
3%
Alopecia
3%
Streptococcal infection
3%
Large intestine perforation
3%
Bacterial sepsis
3%
Cholangitis
3%
Urinary tract obstruction
3%
Confusional state
3%
Device occlusion
3%
Back pain
3%
Rhabdomyolysis
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

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (binimetinib, imatinib)Experimental Treatment2 Interventions
Patients receive binimetinib PO BID on days 1-28 and imatinib PO QD on days 1-28. Cycles repeat every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1250
Imatinib
2011
Completed Phase 3
~3940

Find a Location

Who is running the clinical trial?

Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,349 Total Patients Enrolled
5 Trials studying Melanoma
123 Patients Enrolled for Melanoma
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,925 Total Patients Enrolled
11 Trials studying Melanoma
368 Patients Enrolled for Melanoma
Katy Tsai, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Melanoma
24 Patients Enrolled for Melanoma

Media Library

Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04598009 — Phase 2
Melanoma Research Study Groups: Treatment (binimetinib, imatinib)
Melanoma Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04598009 — Phase 2
Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598009 — Phase 2
~3 spots leftby Jul 2025
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