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Kinase Inhibitor
Encorafenib + Binimetinib +/- Nivolumab for Thyroid Cancer
Phase 2
Recruiting
Led By Matthew H Taylor
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Histologically (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death from any cause, assessed for up to 1 year
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with thyroid cancer that has spread and does not respond to radioiodine treatment. The drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and the immunotherapy may help the body's immune system attack the cancer.
Who is the study for?
This trial is for adults with metastatic, radioiodine-refractory thyroid cancer that has a BRAF V600 mutation. Participants must have measurable disease, be in good physical condition (ECOG status <=1), and not be pregnant or nursing. They should not have had certain prior treatments or conditions that could affect the study's safety.Check my eligibility
What is being tested?
The effectiveness of encorafenib and binimetinib, with or without nivolumab, is being tested on patients with specific thyroid cancer. The goal is to see if these drugs can stop tumor growth by blocking enzymes needed for cell growth and boosting the immune system's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects include fatigue, skin reactions, heart issues like changes in heartbeat rhythm, liver problems such as hepatitis, muscle pain or weakness due to elevated creatine kinase levels, allergic reactions to monoclonal antibodies like nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My thyroid cancer is advanced, does not respond to radioiodine, and has a specific BRAF mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of death from any cause, assessed for up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death from any cause, assessed for up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Incidence of grade >= 3 toxicities
Overall survival
+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%
Infusion related reaction
8%
Weight decreased
8%
Macular oedema
8%
Proteinuria
8%
Iron deficiency
8%
Rhinitis allergic
8%
Hypertrichosis
8%
Nasopharyngitis
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%
Musculoskeletal pain
5%
Rectal haemorrhage
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Bone pain
5%
Hypocalcaemia
5%
Hypophosphataemia
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%
Large intestine perforation
3%
Rhabdomyolysis
3%
Kidney infection
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%
Tumour pain
3%
Cholangitis
3%
Alopecia
3%
Urinary tract infection bacterial
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (encorafenib, binimetinib, nivolumab) - CLOSEDExperimental Treatment3 Interventions
Patients receive encorafenib PO QD and binimetinib PO BID as in arm I. Patients also receive nivolumab IV over 30 minutes on day 1. Cycles with nivolumab repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (encorafenib, binimetinib)Experimental Treatment2 Interventions
Patients receive encorafenib PO QD and binimetinib PO BID on days 1-28. 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
Encorafenib
2021
Completed Phase 3
~960
Binimetinib
2018
Completed Phase 3
~1100
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,495 Total Patients Enrolled
Matthew H TaylorPrincipal InvestigatorProvidence Health & Services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any prohibited medications in the last week.I had major surgery less than 3 weeks ago or am still dealing with its side effects.I have heart problems or significant heart disease.I am allergic to some monoclonal antibody medications.Your heart's QT interval is not longer than 480 milliseconds after being adjusted for your baseline heart rate.Your heart's pumping ability is good, with a left ventricular ejection fraction (LVEF) of 50% or higher.I have a digestive condition that affects how I absorb medication.I have a history of pancreatitis.Your blood and body chemistry need to be within certain ranges.I am fully active and can carry on all pre-disease activities without restriction.I agree to use effective birth control during the study.You have a positive test for HIV, active hepatitis B, or active hepatitis C.I haven't had a stroke or blood clot in the last 3 months.You have a disease that can be measured and confirmed by X-rays or other imaging tests.I have a muscle disorder that might increase my CK levels.I am on steroids or other drugs that affect my immune system.You have an ongoing autoimmune disease, except for certain specific conditions.I haven't had another cancer within the last 3 years, except for certain types.I have previously been treated with immunotherapy.My thyroid cancer is advanced, does not respond to radioiodine, and has a specific BRAF mutation.I have been treated with specific drugs for cancer mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (encorafenib, binimetinib, nivolumab) - CLOSED
- Group 2: Arm I (encorafenib, binimetinib)
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 possible risks could be associated with taking Encorafenib?
"Our team at Power has assigned Encorafenib a safety rating of 2 due to the existing data that supports its security, although efficacy still needs to be demonstrated."
Answered by AI
To what illnesses is encorafenib typically prescribed?
"Encorafenib is often used in the treatment of malignant neoplasms, but it has also been proven to help patients with metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma manage their conditions."
Answered by AI
Is this a pioneering medical experiment?
"Encorafenib has been researched since 2011 when it was first trialled by Pfizer with 183 patients. After successfully passing Phase 2 Drug approval, there are now 767 active trials for this medication in 2571 cities and 51 countries worldwide."
Answered by AI
Is this research endeavor currently recruiting participants?
"Correct. Clinicaltrials.gov reveals that the recruitment for this medical trial--which was first posted on October 30th 2020--is still active, and 40 participants need to be enrolled from a single clinical site."
Answered by AI
Are there any precedents for the use of Encorafenib in clinical trials?
"As of now, there are 767 clinical trials researching Encorafenib with 85 in Phase 3. While some studies for this medication are based in Cambridge, England, a total of 41962 medical centres worldwide have dedicated resources to study its effects."
Answered by AI
What is the sample size of this experiment?
"Affirmative. Information hosted on clinicaltrials.gov shows that this medical research is actively recruiting participants, with the trial first being posted on October 30th 2020 and last updated August 17th 2022. The study requires 40 patients to be recruited from a single site."
Answered by AI
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