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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
Malignancy must express one of the following BRAF alterations: BRAF mutation affecting codon: 241, 257, 367, 462, 463, 464, 466, 467, 469, 485, 581, 586, 594, 595, 596, 597 598, 599, 601; V600 BRAF mutations: V600K (for any malignancy except melanoma), V600D, V600M, V600R; BRAF deletions ie. V600_K601delinsE or 1799_1801 del TGA; BRAF insertions ie. T599dup; BRAF fusions ie. KIAA1549:BRAF
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
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 belowSelect...
My cancer has a specific BRAF gene change.
Select...
I am willing and able to follow the study's requirements, including treatments and check-ups.
Select...
My cancer is advanced, cannot be cured, and standard treatments have failed or are not suitable.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My cancer has a BRAF gene mutation.
BEAVER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 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 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 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%
Iron deficiency
8%
Rhinitis allergic
8%
Hypertrichosis
8%
Nasopharyngitis
8%
Visual impairment
8%
Infusion related reaction
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Pleural effusion
5%
Musculoskeletal pain
5%
Rectal haemorrhage
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Bone pain
5%
Hypophosphataemia
5%
Hypocalcaemia
5%
Nervous system disorder
5%
Ascites
5%
Colitis
5%
Abdominal pain lower
5%
Urinary incontinence
5%
Infection
5%
Wound
5%
Musculoskeletal chest pain
5%
Nail disorder
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%
Device occlusion
3%
Bacterial sepsis
3%
Tumour pain
3%
Kidney infection
3%
Large intestine perforation
3%
Large intestinal ulcer
3%
Confusional state
3%
Upper respiratory tract infection
3%
Large intestinal ulcer hemorrhage
3%
Melanocytic naevus
3%
Back pain
3%
Streptococcal infection
3%
Cholangitis
3%
Alopecia
3%
Urinary tract infection bacterial
3%
Rhabdomyolysis
3%
Hyperkeratosis
3%
Skin papilloma
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
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
1,478 Previous Clinical Trials
485,374 Total Patients Enrolled
Anna Spreafico, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
5 Previous Clinical Trials
341 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You plan to start a new intense exercise routine after your first dose of the study medication.I am older than 18 years.You must be willing and able to follow the study's schedule for visits, treatment, lab tests, and other procedures.I have or am at risk for blocked blood vessels in my eye.I am willing and able to follow the study's requirements, including treatments and check-ups.I have had treatment for inflammatory bowel disease or Crohn's within the last year.My cancer has a specific BRAF gene change.My cancer is advanced, cannot be cured, and standard treatments have failed or are not suitable.I have a history of conditions that increase my risk of blood clots, not related to cancer.I agree to provide a tumor sample for testing before starting treatment.I have a muscle disorder that could increase my CK levels.The investigator thinks you have a health condition that could be risky for you if you participate in the clinical trial, or you might not be able to follow the study procedures properly.I have a history of pancreatitis.My tumor has the BRAF V600E mutation.I have been treated with BRAF or MEK inhibitors before.My cancer is advanced, cannot be cured, and standard treatments have failed or are not suitable.I am willing to provide tumor samples for the study.I am older than 18 years.I haven't had any other cancers in the last 3 years.I am a male and agree to use effective contraception and not donate sperm until 90 days after my last dose.I have HIV that is not currently managed with medication.I am able to understand and follow the study's requirements.My cancer has spread to the lining of my brain and spinal cord.I have a stomach or intestine problem that affects how I absorb medicine.I haven't had chemotherapy, immunotherapy, or targeted therapy in the last 4 weeks.I have brain metastasis causing symptoms.My cancer has a BRAF gene mutation.My melanoma has a BRAF V600K mutation.My organs are functioning well.I am a woman who can have children and my pregnancy test is negative.I had major surgery less than 3 weeks ago or am still dealing with its side effects.You willingly agreed to participate in the study and signed a document confirming your decision.You have a condition that can be measured by a specific medical criteria called RECIST v1.1.You have been fully informed about the study and have agreed to participate.I am fully active and can carry on all my pre-disease activities without restriction.I have heart problems or significant heart disease.I can swallow pills.My condition matches the study's specific disease requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Binimetinib + Encorafenib
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 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
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