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Kinase Inhibitor
Encorafenib/Binimetinib/Nivolumab vs Ipilimumab/Nivolumab for Melanoma
Phase 2
Recruiting
Led By Zeynep Eroglu
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured
Participants must be able to swallow and retain pills
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years after randomization
Awards & highlights
Study Summary
This trial compares the effect of two different drug combinations in treating patients with melanoma that has spread to the brain. One combination is encorafenib and binimetinib, which may stop the growth of tumor cells. The other combination is ipilimumab and nivolumab, which are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
Who is the study for?
This trial is for adults with BRAF-V600 mutant melanoma that has spread to the brain. They must be able to take pills, have a certain level of physical fitness (Zubrod status <=2), and their major organs need to function within specific limits. People with HIV can join if they're on effective therapy. Those who've had other cancers may qualify if it doesn't affect this study's safety or results.Check my eligibility
What is being tested?
The trial compares two treatments for melanoma in the brain: one group receives Encorafenib + Binimetinib + Nivolumab, while the other gets Ipilimumab + Nivolumab. The goal is to see which combination better controls or shrinks brain metastases from melanoma.See study design
What are the potential side effects?
Possible side effects include liver problems, fatigue, skin reactions, digestive issues, changes in blood pressure and heart rhythm, immune system reactions like inflammation in various organs or tissues, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had hepatitis C but have been treated and cured.
Select...
I can swallow and keep down pills.
Select...
My melanoma has a BRAF-V600 mutation, confirmed by a certified lab.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have a brain scan showing a tumor larger than 0.5 cm.
Select...
My melanoma has spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Duration of response
Intracranial response rate (ICRR)
Objective response rate
+1 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%
Rhinitis allergic
8%
Infusion related reaction
8%
Iron deficiency
8%
Nasopharyngitis
8%
Hypertrichosis
8%
Visual impairment
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Pleural effusion
5%
Rectal haemorrhage
5%
Hypophosphataemia
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Bone pain
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Hypocalcaemia
5%
Nervous system disorder
5%
Ascites
5%
Abdominal pain lower
5%
Colitis
5%
Urinary incontinence
5%
Infection
5%
Wound
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%
Bacterial sepsis
3%
Device occlusion
3%
Large intestine perforation
3%
Large intestinal ulcer hemorrhage
3%
Confusional state
3%
Back pain
3%
Kidney infection
3%
Large intestinal ulcer
3%
Skin papilloma
3%
Upper respiratory tract infection
3%
Tumour pain
3%
Streptococcal infection
3%
Melanocytic naevus
3%
Cholangitis
3%
Alopecia
3%
Urinary tract infection bacterial
3%
Rhabdomyolysis
3%
Hyperkeratosis
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (nivolumab, ipilimumab)Experimental Treatment2 Interventions
Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (encorafenib, binimetinib, nivolumab)Experimental Treatment3 Interventions
Patients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1100
Encorafenib
2021
Completed Phase 3
~960
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,058 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,020 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,699 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation therapy in the last 7 days.I had hepatitis C but have been treated and cured.I am using effective birth control.I do not have a serious infection needing treatment according to my doctor.I haven't had severe side effects from ipilimumab or nivolumab that needed long-term steroids.I have HIV, am on effective treatment, and my recent tests show no detectable virus.Your creatinine level is within a certain range, which means your kidneys are working well.I have not stopped taking encorafenib or binimetinib due to side effects.My cancer has spread outside of my brain.My liver enzymes are within the required range for the study.I will not seek other cancer treatments while in this study.I am taking up to 8 mg of dexamethasone daily for brain metastases.I can swallow and keep down pills.I have another cancer, but it won't affect this trial's treatment.My melanoma has a BRAF-V600 mutation, confirmed by a certified lab.Your platelet count is at least 75,000 per microliter within the last 28 days before joining the study.I can take care of myself but might not be able to do heavy physical work.I had a full health check-up within the last 28 days.Your white blood cell count needs to be at least 1,500/mcL within the last 28 days before the study starts.Your total bilirubin level is less than or equal to the upper limit of normal at the hospital (within the past 28 days).I have another cancer, but it won't affect this trial's treatment.I have a brain scan showing a tumor larger than 0.5 cm.Your hemoglobin level should be at least 8.0 grams per deciliter within the last 28 days before starting the study.My melanoma has spread to my brain.I haven't been treated for an autoimmune disease with biologic agents in the last 6 months.I have not had any drug treatments for cancer that has spread.I have a heart condition or have been treated with heart-toxic drugs and need a heart function assessment.My cancer has spread to the lining of my brain and spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (encorafenib, binimetinib, nivolumab)
- Group 2: Arm II (nivolumab, ipilimumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions does Encorafenib help alleviate?
"Encorafenib is a medication that can be used to treat previous anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."
Answered by AI
Are there many places conducting this research in Canada?
"There are a total of 100 locations where this clinical trial is taking place. Some notable places where patients can receive treatment include Moffitt Cancer Center-International Plaza in Tampa, Saint Luke's Cancer Institute - Meridian in Meridian, and Cancer Care Specialists of Illinois - Decatur in Decatur."
Answered by AI
How many people are enrolled in this research project?
"Yes, this is an active clinical trial that was posted on September 23rd, 2020 and updated November 9th, 2020. They are looking for 112 patients at 100 sites."
Answered by AI
Are there other drugs in Encorafenib's class that have undergone clinical testing?
"There are 846 trials underway that involve encorafenib. 89 of those studies are currently in Phase 3. However, these aren't the only ongoing investigations, as there 44911 locations running similar experiments."
Answered by AI
Is there a high potential for harm when taking Encorafenib?
"Encorafenib's safety is based on preliminary Phase 2 data, meaning that while there are some indications it is safe, there is no evidence yet of efficacy."
Answered by AI
Are there still opportunities for people to enroll in this trial?
"That is correct, the listing on clinicaltrials.gov affirms that this study is still recruiting patients. This trial was first announced on September 23rd 2020 and updated November 9th 2022. There is a need for 112 participants who will be spread out over 100 different centres."
Answered by AI
Who else is applying?
What site did they apply to?
Providence Saint Vincent Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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