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Kinase Inhibitor

Binimetinib + Encorafenib for Solid Cancers (BEAVER Trial)

Phase 2
Waitlist Available
Led By Anna Spreafico, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years, male or female.
Disease characteristics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

BEAVER Trial Summary

This trial is testing if two drugs can stop the growth of cancer in patients with class 2 or 3 BRAF mutations when no other standard therapy is available.

Who is the study for?
Adults with advanced solid tumors that have specific non-V600E BRAF mutations, who can swallow pills and provide tumor biopsies. They must not have standard treatment options or must have failed previous therapies. Excluded are those with certain BRAF mutations, recent treatments, brain metastasis, heart issues, active infections like HIV or hepatitis B/C, pancreatitis history, gastrointestinal diseases affecting drug absorption, neuromuscular disorders potentially elevating CK levels.Check my eligibility
What is being tested?
The trial is testing the effectiveness of binimetinib and encorafenib taken orally on patients with advanced solid tumors harboring class 2 and 3 BRAF mutations. It aims to see how well these drugs stop cancer growth in patients without other treatment options.See study design
What are the potential side effects?
Potential side effects include fatigue; skin reactions; vision changes; heart problems; liver enzyme changes leading to inflammation; muscle pain or weakness; increased risk of bleeding or clotting events. Side effects vary by individual.

BEAVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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My condition matches the study's specific disease requirements.
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My cancer is advanced, cannot be cured, and standard treatments have failed or are not suitable.
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My cancer has a specific BRAF gene change.
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I am willing to provide tumor samples for the study.
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I can swallow pills.
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I am willing and able to follow the study's requirements, including treatments and check-ups.
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My cancer is advanced, cannot be cured, and standard treatments have failed or are not suitable.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My cancer has a BRAF gene mutation.

BEAVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 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
Objective response rate defined as per RECIST v1.1.
Secondary outcome measures
Change in circulating tumor DNA (ctDNA) profiles measured by serial analysis of ctDNA profiles at baseline, mid-cycle 1, with each subsequent cycle, and at progression, validated by comparison to molecular profiles of corresponding fresh tumor biopsies
Disease Control Rate defined in accordance with RECIST v1.1, as the percentage of patients who achieve a complete response, partial response or stable disease after 24 weeks of treatment.
Disease progression defined as per RECIST v1.1 and monitored throughout the study period. Progression Free Survival defined as time from study registration to disease progression or death from any cause.
+4 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%
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%
Cholangitis
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%
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

BEAVER Trial Design

1Treatment groups
Experimental Treatment
Group I: Binimetinib + EncorafenibExperimental Treatment2 Interventions
Binimetinib and encorafenib are administered orally on a twice daily or once daily schedule, respectively in 28-day cycles. Treatment will continue until it is discontinued due to unacceptable toxicity, clinical or radiological disease progression as per RECIST 1.1, investigator decision, and/or withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
FDA approved
Binimetinib
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,773 Total Patients Enrolled
Anna Spreafico, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
5 Previous Clinical Trials
341 Total Patients Enrolled

Media Library

Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03839342 — Phase 2
Solid Tumors Research Study Groups: Binimetinib + Encorafenib
Solid Tumors Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT03839342 — Phase 2
Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03839342 — Phase 2

Frequently Asked Questions

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

What safety protocols have been observed with Binimetinib treatments?

"There is some evidence of Binimetinib's safety, thus it has been assigned a score of 2 on the 1-3 scale. The Phase 2 designation means that there is no available data to demonstrate efficacy at this time."

Answered by AI

Is this experimental research the inaugural venture of its kind?

"Binimetinib has been the object of research since 2011, when Pfizer sponsored its inaugural trial involving 183 patients. Since then, it recieved Phase 2 approval and there are currently 63 studies concerning Binimetinib occurring across 1256 cities in 41 countries."

Answered by AI

Has there been any extant research on the use of Binimetinib?

"At the moment, 63 experiments related to Binimetinib are underway. 4 of them have advanced beyond Phase 3 clinical trials. While Orange City Florida has a disproportionately high concentration of studies on this drug, there are 3543 other locations running such tests globally."

Answered by AI

What has Binimetinib been traditionally used to treat?

"Binimetinib has been approved as a therapeutic agent for metastatic melanoma and unresectable melanoma with the BRAF V600K mutation."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Affirmative. Clinicaltrials.gov states that the trial, which was posted on June 7th 2019, is recruiting patients for participation at a single medical site with a target of 26 participants."

Answered by AI

Is enrollment currently available for this trial?

"Affirmative. The clinicaltrials.gov page displays that this medical project, which was originally posted on June 7th 2019, requires volunteers at the present moment. Around 26 individuals will be accepted at a single location for participation in the research study."

Answered by AI
~5 spots leftby Mar 2025