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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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My melanoma cannot be surgically removed and is in an advanced stage.
Select...
I am HIV-positive, on treatment, and my viral load is undetectable.
Select...
My melanoma has a KIT mutation, confirmed by a certified test.
Select...
I had hepatitis C but am cured or currently being treated with no detectable virus.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR)
Median duration of response
Overall survival (OS)
+2 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 (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
~1100
Imatinib
2011
Completed Phase 3
~3940
Find a Location
Who is running the clinical trial?
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,372 Total Patients Enrolled
5 Trials studying Melanoma
148 Patients Enrolled for Melanoma
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,530 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to binimetinib or any of its ingredients.My hepatitis B virus load is undetectable with treatment.You have a detectable tumor according to specific measurement guidelines.I have or am at risk for blocked veins in my eye.My blood, liver, and kidney functions are all within normal ranges.I can take care of myself but might not be able to do heavy physical work.I have a digestive condition that affects how I absorb medication.I cannot swallow or keep down the medication.I have heart problems or significant heart disease.My melanoma diagnosis was confirmed through lab tests.I am taking medication that cannot be stopped safely before starting the study treatment.I haven't had cancer treatments or radiation in the last 3 weeks, or antibody therapy in the last 4 weeks.My melanoma cannot be surgically removed and is in an advanced stage.I have recovered from previous cancer treatment side effects, except for stable chronic conditions.I do not have any severe health or mental conditions that could worsen by joining this study.I had immune therapy before surgery, but my last dose was over 4 weeks ago.I am HIV-positive, on treatment, and my viral load is undetectable.I haven't had a stroke or blood clot in the last 3 months.I am not currently on any experimental drugs and haven't been for the last 14 days or 5 half-lives of the drug.My melanoma has a KIT mutation, confirmed by a certified test.I had hepatitis C but am cured or currently being treated with no detectable virus.My cancer has worsened despite treatment, or I can't handle the standard treatment.I do not have any other cancer that could affect the treatment's safety or results.I am using effective birth control and will notify my doctor if I become pregnant.I have a muscle disorder that causes high CK levels.I am a sexually active man willing to use contraception and not donate sperm.I don't need immediate brain or spinal cord treatment for cancer spread.I cannot switch from warfarin to another blood thinner safely.You are allergic to imatinib or any of its ingredients.I had immunotherapy for my cancer, but my last dose was over 4 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (binimetinib, imatinib)
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.
What are the potential risks of Binimetinib to patients?
"The safety rating of Binimetinib is a 2, as there has been some evidence to support its safety profile but no data demonstrating efficacy in clinical trials."
Answered by AI
Is this research endeavor actively enlisting participants?
"The current status of the medical trial, as per clinicaltrials.gov, is actively recruiting patients. It was first listed on March 3rd 2021 and recently updated on December 3rd 2021."
Answered by AI
Have any other investigations utilized Binimetinib?
"Currently, there are 110 studies regarding binimetinib in progress with 18 of those trials having progressed to phase 3. While Cambridge England hosts several of these investigations, clinical trails related to Binimetinib can be found at 4,872 distinct sites worldwide."
Answered by AI
What conditions can Binimetinib provide relief for?
"Binimetinib is primarily employed to treat newly diagnosed acute lymphoblastic leukaemia. Other conditions that may benefit from this pharmaceutical include unresectable melanoma, refractory ALL, and muscular dystrophy."
Answered by AI
What is the aggregate size of this research cohort?
"Correct. Clinicaltrials.gov verifies that this research project, initially posted on March 3rd 2021, is now actively accepting participants. 25 volunteers are sought from a single medical site."
Answered by AI
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