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MEK Inhibitor
Binimetinib + Nivolumab for Skin Cancer
Phase 2
Recruiting
Led By Roger Lo, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
V600BRAF wildtype tumor status confirmed by Clinical Laboratory Improvement Act (CLIA) approved lab
Histologically confirmed locally advanced/unresectable or metastatic cutaneous melanoma
Must not have
Inability to swallow and retain study drug
History or current evidence of retinal venous occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 months
Awards & highlights
Summary
This trial studies how well binimetinib and nivolumab work in treating patients with melanoma. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving binimetinib and nivolumab together may work better in treating patients with melanoma compared to nivolumab alone.
Who is the study for?
Adults with advanced melanoma that can't be surgically removed or has spread, and who have not responded to previous immunotherapy. They must have normal organ function, no uncontrolled brain metastases, no history of certain heart diseases or severe lung conditions, and cannot be pregnant or breastfeeding. Participants need a tumor suitable for biopsy and agree to use effective contraception.
What is being tested?
The trial is testing the combination of Binimetinib (a drug blocking enzymes for cell growth) with Nivolumab (an antibody boosting the immune system against cancer). It aims to see if this combo is more effective than Nivolumab alone in treating unresectable or metastatic BRAF V600 wildtype melanoma.
What are the potential side effects?
Possible side effects include skin reactions, high blood pressure, muscle pain, fatigue, nausea, liver issues like elevated enzyme levels in the blood tests indicating potential damage; also risks related to immune system activation such as inflammation in organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor does not have the V600BRAF mutation.
Select...
My melanoma cannot be removed by surgery and has spread.
Select...
My cancer did not respond to previous immunotherapy treatments.
Select...
My cancer can be measured by scans or visible and measured with a picture.
Select...
I am fully active or can carry out light work.
Select...
I agree to use contraception or abstain from sex for 5 months after my last treatment dose.
Select...
I can have a biopsy on my cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot swallow or keep down the medication.
Select...
I do not have a history of eye blood vessel blockage or diseases that increase its risk.
Select...
I am allergic to binimetinib or its ingredients.
Select...
I haven't had major surgery in the last 6 weeks or still recovering from one.
Select...
I have a muscle disorder that increases my CK levels.
Select...
I am taking more than 10 mg of prednisone or its equivalent daily for another condition.
Select...
I have not had a stroke or significant blood clot in the last 3 months.
Select...
I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.
Select...
I am unable to understand and agree to the study's details.
Select...
I am not currently on any experimental or standard cancer treatments.
Select...
I have recovered from the side effects of my previous cancer treatment.
Select...
I cannot have a tumor biopsy due to bleeding disorders or severe scarring.
Select...
I have previously been treated with a MEK inhibitor.
Select...
I have had treatments for cancer that has spread, not counting initial or maintenance therapy.
Select...
I have or had lung inflammation that needed steroids.
Select...
I am not pregnant or breastfeeding.
Select...
I have or had inflammatory bowel disease.
Select...
I do not have any stomach or bowel problems that could affect how a medicine works in my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 26 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 months
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
Secondary study objectives
Clinical benefit rate
Duration of response
Overall survival
+1 moreOther study objectives
Pharmacodynamic marker analysis
Side 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%
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%
Pollakiuria
11%
Trichiasis
11%
Vitreous floaters
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Rhinitis allergic
8%
Nasopharyngitis
8%
Visual impairment
8%
Hypokalaemia
8%
Macular oedema
8%
Iron deficiency
8%
Hypertrichosis
8%
Infusion related reaction
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%
Pleural effusion
5%
Infection
5%
Rectal haemorrhage
5%
Wound
5%
Nervous system disorder
5%
Hypocalcaemia
5%
Hypophosphataemia
5%
Musculoskeletal pain
5%
Restless legs syndrome
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%
Upper respiratory tract infection
3%
Kidney infection
3%
Urinary tract infection bacterial
3%
Large intestinal ulcer
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Alopecia
3%
Skin papilloma
3%
Streptococcal infection
3%
Melanocytic naevus
3%
Epistaxis
3%
Large intestinal ulcer hemorrhage
3%
Tumour pain
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (binimetinib, nivolumab)Experimental Treatment3 Interventions
Patients receive binimetinib PO BID on days 1-28 and nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Binimetinib
2018
Completed Phase 3
~1200
Find a Location
Who is running the clinical trial?
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,369 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
29,401 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,617 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow or keep down the medication.I do not have a history of eye blood vessel blockage or diseases that increase its risk.I am allergic to binimetinib or its ingredients.I haven't had major surgery in the last 6 weeks or still recovering from one.I experienced severe side effects from my first anti-PD-1 cancer treatment.Your white blood cell count is at least 2,000 per cubic millimeter.Your hemoglobin level is at least 8.0 grams per deciliter.I had radiotherapy more than 14 days ago or have recovered from its side effects.You are being held against your will for treatment of a psychiatric or physical illness.I have an autoimmune disease but it's controlled or minor like type I diabetes, hypothyroidism, vitiligo, psoriasis, or alopecia.Your albumin levels are equal to or greater than 2.5 grams per deciliter.I have a muscle disorder that increases my CK levels.I am taking more than 10 mg of prednisone or its equivalent daily for another condition.I have not had a stroke or significant blood clot in the last 3 months.My tumor does not have the V600BRAF mutation.I agree to use effective birth control or abstain from sex during the study and for 5 months after.I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.My melanoma cannot be removed by surgery and has spread.I haven't had cancer treatment or experimental drugs in the last 14 days.I have been cancer-free for 2 years, except for certain skin or superficial cancers.I am unable to understand and agree to the study's details.Women who could become pregnant must have a negative pregnancy test before starting the study drug.My brain metastases are stable, not requiring steroids, and I haven't had radiation in the last 28 days.My cancer did not respond to previous immunotherapy treatments.Your bilirubin levels must be within a certain range, unless you have a condition called Gilbert's disease, in which case it must be within a higher range.My heart pumps well, as shown by a recent heart scan.I am not currently on any experimental or standard cancer treatments.I have recovered from the side effects of my previous cancer treatment.My cancer can be measured by scans or visible and measured with a picture.Your platelet count is at least 75,000 per cubic millimeter.I cannot have a tumor biopsy due to bleeding disorders or severe scarring.I do not have serious heart problems.I have previously been treated with a MEK inhibitor.I have had treatments for cancer that has spread, not counting initial or maintenance therapy.I have or had lung inflammation that needed steroids.Your liver enzymes (AST and ALT) are not more than 3 times the normal limit, or 5 times the normal limit if you have cancer that has spread to the liver.I am not pregnant or breastfeeding.I have or had inflammatory bowel disease.I am 18 years old or older.I am fully active or can carry out light work.I agree to use contraception or abstain from sex for 5 months after my last treatment dose.I do not have any stomach or bowel problems that could affect how a medicine works in my body.I can have a biopsy on my cancer.Your kidney function, as measured by a blood test, is within a certain range.Your absolute neutrophil count is at least 1,500 per cubic millimeter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (binimetinib, nivolumab)
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.
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