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Kinase Inhibitor

Encorafenib for Colorectal Cancer

Phase 1

Waitlist Available

Led By Chloe E Atreya, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat patients with metastatic colorectal cancer. The drugs may stop the growth of tumor cells and help the body's immune system attack the cancer.

Eligible Conditions

Colorectal Cancer
Rectal Cancer
Colon Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Best investigator-assessed response

Incidence of treatment-related grade 3 or higher adverse events (AEs)

Radiographic Response

Secondary outcome measures

Disease control rate (DCR)

Duration of response

Overall survival

+2 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%

Trichiasis

11%

Vitreous floaters

11%

Pollakiuria

11%

Dyspepsia

11%

Hypoalbuminaemia

11%

Hypertension

11%

Tumour Pain

Weight decreased

Macular oedema

Proteinuria

Rhinitis allergic

Iron deficiency

Nasopharyngitis

Infusion related reaction

Hypertrichosis

Visual impairment

Hypokalaemia

Flank pain

Rash

Pruritus

Pain in extremity

Blood bilirubin increased

Rhinnorrhoea

Hypotension

Rectal haemorrhage

Hypophosphataemia

Bone pain

Restless legs syndrome

Pruritus generalised

Chorioretinopathy

Trichomegaly

Urinary incontinence

Musculoskeletal chest pain

Pleural effusion

Musculoskeletal pain

Hypocalcaemia

Nervous system disorder

Ascites

Abdominal pain lower

Nail disorder

Colitis

Infection

Wound

Anal haemorrhage

Insomnia

Gastroesophageal reflux disease

Abdominal distension

Eczema

Cystitis

Renal failure

Conjunctivitis

Syncope

Dehydration

Dry Mouth

Skin hyperpigmentation

Muscle spasms

Erythema

Retinal detachment

Pulmonary embolism

Dysphonia

Haematuria

Blood creatinine increased

Depression

Palpitations

Large intestinal ulcer hemorrhage

Urinary tract infection bacterial

Back pain

Kidney infection

Large intestinal ulcer

Upper respiratory tract infection

Tumour pain

Streptococcal infection

Melanocytic naevus

Large intestine perforation

Cholangitis

Device occlusion

Skin papilloma

Alopecia

Bacterial sepsis

Rhabdomyolysis

Confusional state

Hyperkeratosis

Rectal hemorrhage

Urinary tract obstruction

Epistaxis

Colon cancer

Sepsis

Acute kidney injury

Large intestine ulcer

Neutropenia

Bacteria sepsis

Hydronephrosis

Neuropathy peripheral

Abdominal abscess

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Combined Safety Lead-in

Phase 3: Triplet Arm

Phase 3: Doublet Arm

Phase 3: Control Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (encorafenib, binimetinib, nivolumab)Experimental Treatment4 Interventions

Participants in Phase 1 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 for a maximum of 24 cycles of treatment in the absence of disease progression or unacceptable toxicity. The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Binimetinib

2018

Completed Phase 3

~1100

Encorafenib

2021

Completed Phase 3

~960

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,553 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,498 Total Patients Enrolled

PfizerIndustry Sponsor

4,568 Previous Clinical Trials

10,911,884 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for individuals in this test?

"This clinical trial is not recruiting participants at the moment. The first posting was on 8/31/2020 and the most recent update was on 3/22/2022. However, there are 2069 trials actively recruiting participants with colorectal carcinoma and 797 studies for Encorafenib that are enrolling patients."

Answered by AI

How many people can join this research project?

"Currently, this clinical trial is not looking for more participants. The study was first posted on 8/31/2020 and was most recently edited on 3/22/2022. However, if you are interested in other trials, there are 2069 studies actively admitting patients with colorectal carcinoma and 797 trials for Encorafenib enrolling new patients right now."

Answered by AI

What is the efficacy of Encorafenib in other areas?

"Encorafenib is being studied in 797 different clinical trials, 85 of which are Phase 3. The largest proportion of these studies are based out of Cambridge, England; however, there are 41985 total locations running trials for this treatment."

Answered by AI

What are the common indications for Encorafenib?

"Encorafenib is a medication that oncologists frequently prescribe to treat malignant neoplasms. Additionally, it can be used as part of the treatment plan for other conditions such as unresectable melanoma and squamous cell carcinoma."

Answered by AI

What is the primary objectives of this clinical trial?

"The primary outcome of this trial will be the best investigator-assessed response, which will be measured over a 100-day period after the last dose. Secondary outcomes include disease control rate (DCR), duration of response, and time to response criteria. DCR will be estimated by the proportion of patients with CR, PR, or SD defined by irRECIST criteria in the evaluable population. The point estimate of DCR and its 95% confidence interval will be obtained. Duration of response will be estimated by Kaplan-Meier method and summarized with Kaplan-Meier curves and log rank test from first partial or CR to"

Answered by AI

Has this type of clinical trial been done before?

"Encorafenib has been researched since 2010, with the first study being sponsored by Medarex. After this initial trial involving 127 people, Encorafenib received Phase 1 drug approval in ____ . Currently, there are 797 active trials for Encorafenib across 2560 cities and 52 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Chloe Atreya, MD, PhD 2020. "Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04044430.