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Kinase Inhibitor
Triple Drug Therapy for Advanced Melanoma
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory
Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma
Must not have
Known history of a positive test for HIV or known AIDS
Participants who previously received and subsequently discontinued encorafenib and/or binimetinib and/or anti-PD-1/-L1 due to severe toxicity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of every 3 cycles: c4d1, c7d1, c10d1, etc. for the first 24 months and then day 1 of every 4 cycles after 24 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing a combination of three drugs to treat advanced skin cancer in patients with a specific genetic mutation. One drug helps the immune system fight cancer, while the other two stop cancer cells from growing. The study aims to see if this combination is safe and effective.
Who is the study for?
Adults with advanced or metastatic melanoma that has a specific BRAF gene mutation and no prior treatment for their condition. They must be able to follow the study plan, have at least one measurable lesion, proper organ function, and an ECOG status of 0 or 1. Exclusions include significant heart disease history, recent serious blood clots or strokes, active infections requiring treatment, brain metastases involvement, certain medication use within specified timeframes before the trial starts.
What is being tested?
The trial is testing a combination of three drugs: Encorafenib and Binimetinib taken orally daily at home along with Pembrolizumab given via IV every three weeks in the clinic. The goal is to assess their effectiveness when used together against melanoma that hasn't been treated before.
What are the potential side effects?
Potential side effects may include fatigue, skin reactions, liver problems (like hepatitis), muscle pain or weakness (myopathy), allergic reactions including swelling under the skin (angioedema) and infusion-related reactions from Pembrolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma has a BRAF V600 mutation confirmed by a certified test.
Select...
I haven't had systemic therapy for advanced melanoma.
Select...
I am 18 years old or older.
Select...
My skin cancer is at an advanced stage and cannot be surgically removed.
Select...
I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have tested positive for HIV/AIDS.
Select...
I stopped taking encorafenib, binimetinib, or anti-PD-1/-L1 due to severe side effects.
Select...
I have or had lung inflammation not caused by infection, treated with steroids.
Select...
I have or had brain metastases or cancer spread to the lining of the brain.
Select...
I cannot swallow or absorb pills.
Select...
I have not been treated for an infection with medication in the last 2 weeks.
Select...
My melanoma is located in the mucosal or ocular area.
Select...
I am not allergic to encorafenib, binimetinib, pembrolizumab, or their ingredients.
Select...
I have a muscle disorder that could increase my CK levels.
Select...
I have a serious heart condition.
Select...
I have an immune system disorder that needed treatment in the last 2 years.
Select...
I have a digestive issue that affects how my body absorbs medication.
Select...
I have or am at risk for retinal vein occlusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the date of randomization to the date of death due to any cause.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the date of randomization to the date of death due to any cause.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 3: Objective Response (OR) by Blinded Independent Central Review (BICR)
Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs)
Secondary study objectives
Phase 3: Change from baseline in 5-level EuroQol-5D (EQ-5D-5L) index score and visual analog scale (VAS)
Melanoma
Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) score
+11 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Triplet ArmExperimental Treatment3 Interventions
Encorafenib and Binimetinib in combination with Pembrolizumab
Group II: Control ArmActive Control1 Intervention
Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1250
Pembrolizumab
2017
Completed Phase 3
~2810
Encorafenib
2022
Completed Phase 3
~970
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Encorafenib, a BRAF inhibitor, targets and inhibits the activity of the mutated BRAF protein, which is involved in cell growth and proliferation in melanoma cells. Binimetinib, a MEK inhibitor, works downstream of BRAF in the same pathway, further blocking cell growth signals.
Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These mechanisms are crucial for melanoma patients as they directly target the genetic mutations and immune evasion strategies that drive melanoma progression, offering a more personalized and effective treatment approach.
[What's new in oncology?].
[What's new in oncology?].
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Who is running the clinical trial?
PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,025 Total Patients Enrolled
54 Trials studying Melanoma
49,295 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,184,985 Total Patients Enrolled
124 Trials studying Melanoma
21,925 Patients Enrolled for Melanoma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,201 Total Patients Enrolled
28 Trials studying Melanoma
3,269 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least one detectable abnormality that can be seen on a scan or in a photo according to certain guidelines.You have signs of hepatitis B or C virus infection.I haven't had any cancer except for certain skin, prostate, or cervical pre-cancers in the last 2 years.My melanoma has a BRAF V600 mutation confirmed by a certified test.I have tested positive for HIV/AIDS.I stopped taking encorafenib, binimetinib, or anti-PD-1/-L1 due to severe side effects.You have severe allergies to multiple medications, cannot tolerate topical corticosteroids, or have severe reactions after treatment.I am using or might need drugs that strongly affect how my body processes some medications.I have or had lung inflammation not caused by infection, treated with steroids.I have or had brain metastases or cancer spread to the lining of the brain.I have recovered from major side effects of my previous cancer treatments.I haven't had systemic therapy for advanced melanoma.I cannot swallow or absorb pills.I have not had a stroke or blood clot in the last 3 months.I have not been treated for an infection with medication in the last 2 weeks.You have a medical or mental condition, or recent thoughts of harming yourself, that could make it risky for you to be in the study.My melanoma is located in the mucosal or ocular area.I am not allergic to encorafenib, binimetinib, pembrolizumab, or their ingredients.I can provide a sample of my tumor for testing.My bone marrow, liver, and kidneys are functioning well.I am 18 years old or older.My skin cancer is at an advanced stage and cannot be surgically removed.I am willing and able to follow all study requirements.I have a muscle disorder that could increase my CK levels.I have a serious heart condition.I am fully active or can carry out light work.I have an immune system disorder that needed treatment in the last 2 years.I am able to understand and sign the consent form.I have a digestive issue that affects how my body absorbs medication.I have or am at risk for retinal vein occlusion.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Triplet Arm
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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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