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Encorafenib+ Cetuximab

Phase 2

Colorectal Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 2, 2025

Target and mechanism

Molecular targetBRAF
Target classInhibitor
ModalitySmall molecule

Also known as Encorafenib Oral Capsule, Encorafenib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Encorafenib+ Cetuximab · 1 trial · 2 indications

Phase 2 1
NCT05706779Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum CancerColorectal Cancer
RECRUITING30 Analytics
PHASE2RECRUITING
Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the rate of significant tumour regression (TRG 0 to 2 according to Ryan's modified score of the AJCC 2010)
6 months after completing inclusions

with centralised review after neoadjuvant treatment with encorafenib and cetuximab, in patients with RAS wild type localised colon or upper rectum cancer (CC) and carriers of the BRAF V600E mutation.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Encorafenib + CetuximabEXPERIMENTAL -

Interventions

NameTypeDescription
Encorafenib Oral Capsule + CetuximabDRUGEncorafenib: 4 capsules 75 mg/day (300 mg) , 7 days/7 during 6 weeks Cetuximab: 500mg/m2 intravenous route every 2 weeks (D1, D14, D28), for 3 cycles over 4 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Informed consent signed and dated by the patient and the investigator * Age ≥18 years at time of informed consent * Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E determined ...

Countries:France
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Frequently asked questions about Encorafenib+ Cetuximab

What is Encorafenib used for?

Encorafenib is an investigational small molecule being studied for the treatment of BRAF V600E-mutant metastatic colorectal cancer and BRAF V600E colorectal cancer. It is being evaluated in combination with other agents such as cetuximab and binimetinib in clinical trials.

What does Encorafenib target?

Encorafenib targets kinases, as it belongs to the -nib class of kinase inhibitors. It is specifically being studied in patients with BRAF V600E mutations, indicating its role in targeting the BRAF V600E-mutant pathway in colorectal cancer.

Who makes Encorafenib?

Encorafenib is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with BRAF V600E-mutant colorectal cancer.

What phase is Encorafenib in?

Encorafenib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 2 trials are ongoing or completed to assess its effectiveness in treating BRAF V600E-mutant colorectal cancer.

What clinical trials is Encorafenib in?

Encorafenib is being studied in several Phase 2 trials, including NCT03693170, NCT05004350, and NCT05706779. These trials evaluate combinations with cetuximab and binimetinib in patients with BRAF V600E-mutant colorectal cancer, with some trials completed and one currently recruiting.

Is Encorafenib the same as Encorafenib Oral Capsule?

Yes, Encorafenib is also known as Encorafenib Oral Capsule, Encorafenib Oral Capsule + Cetuximab, and Encorafenib + Cetuximab. These names refer to the same drug, often described in the context of its combination therapy with cetuximab for treating colorectal cancer.