Completed

ANCHOR-CRCPhase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

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What is being tested

encorafenib

+ Binimetinib

+ Cetuximab

Drug
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2019
See protocol details

Summary

Principal SponsorPierre Fabre Medicament
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 17, 2019

Actual date on which the first participant was enrolled.

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. It will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (PK) of encorafenib, binimetinib, and cetuximab.

Official TitlePhase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer
NCT03693170
Principal SponsorPierre Fabre Medicament
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

95 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

8 inclusion criteria required to participate
Male or female ≥ 18 years of age
Histologically or cytologically confirmed CRC that is metastatic
Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening
Evidence of measurable disease as per RECIST, v1.1
Show More Criteria
9 exclusion criteria prevent from participating
Prior systemic therapy for metastatic disease
Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
Symptomatic brain metastasis or Leptomeningeal disease
History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
encorafenib plus binimetinib plus cetuximab

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 45 locations

Suspended

Pierre Fabre Investigative Site

Koto-ku,, JapanOpen Pierre Fabre Investigative Site in Google Maps
Suspended

St Antonius Ziekenhuis

Utrecht, Netherlands
Suspended

Hospital Puerta de Hierro

Madrid, Spain
Suspended

Complejo Hospitalario De Navarra S Oncologia Medica

Pamplona, Spain
Completed45 Study Centers