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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

No Placebo-Only Group

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 below

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My tumor does not have the V600BRAF mutation.

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My melanoma cannot be removed by surgery and has spread.

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My cancer did not respond to previous immunotherapy treatments.

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My cancer can be measured by scans or visible and measured with a picture.

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I am fully active or can carry out light work.

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I agree to use contraception or abstain from sex for 5 months after my last treatment dose.

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I can have a biopsy on my cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow or keep down the medication.

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I do not have a history of eye blood vessel blockage or diseases that increase its risk.

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I am allergic to binimetinib or its ingredients.

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I haven't had major surgery in the last 6 weeks or still recovering from one.

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I have a muscle disorder that increases my CK levels.

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I am taking more than 10 mg of prednisone or its equivalent daily for another condition.

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I have not had a stroke or significant blood clot in the last 3 months.

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I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.

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I am unable to understand and agree to the study's details.

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I am not currently on any experimental or standard cancer treatments.

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I have recovered from the side effects of my previous cancer treatment.

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I cannot have a tumor biopsy due to bleeding disorders or severe scarring.

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I have previously been treated with a MEK inhibitor.

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I have had treatments for cancer that has spread, not counting initial or maintenance therapy.

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I have or had lung inflammation that needed steroids.

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I am not pregnant or breastfeeding.

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I have or had inflammatory bowel disease.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 months 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

Secondary study objectives

Clinical benefit rate

Duration of response

Overall survival

+1 more

Other study objectives

Pharmacodynamic marker analysis

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

Rhinitis allergic

Infusion related reaction

Hypokalaemia

Visual impairment

Macular oedema

Hypertrichosis

Iron deficiency

Nasopharyngitis

Weight decreased

Flank pain

Proteinuria

Rash

Pruritus

Pain in extremity

Blood bilirubin increased

Rhinnorrhoea

Hypotension

Pleural effusion

Restless legs syndrome

Nervous system disorder

Wound

Trichomegaly

Infection

Hypocalcaemia

Hypophosphataemia

Rectal haemorrhage

Musculoskeletal pain

Anal haemorrhage

Ascites

Colitis

Abdominal pain lower

Nail disorder

Pruritus generalised

Bone pain

Musculoskeletal chest pain

Chorioretinopathy

Urinary incontinence

Insomnia

Gastroesophageal reflux disease

Abdominal distension

Eczema

Cystitis

Renal failure

Conjunctivitis

Syncope

Dehydration

Dry Mouth

Skin hyperpigmentation

Muscle spasms

Erythema

Retinal detachment

Pulmonary embolism

Dysphonia

Haematuria

Blood creatinine increased

Depression

Palpitations

Tumour pain

Urinary tract infection bacterial

Melanocytic naevus

Large intestinal ulcer

Kidney infection

Large intestinal ulcer hemorrhage

Epistaxis

Hyperkeratosis

Rectal hemorrhage

Streptococcal infection

Alopecia

Upper respiratory tract infection

Skin papilloma

Large intestine perforation

Bacterial sepsis

Cholangitis

Urinary tract obstruction

Confusional state

Device occlusion

Back pain

Rhabdomyolysis

Colon cancer

Sepsis

Acute kidney injury

Large intestine ulcer

Neutropenia

Bacteria sepsis

Hydronephrosis

Neuropathy peripheral

Abdominal abscess

Hyperglycaemia

100%

80%

60%

40%

20%

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, 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

2015

Completed Phase 3

~4010

Binimetinib

2018

Completed Phase 3

~1250