BRAF V600E-mutant Metastatic Colorectal CancerPhase 2ANCHOR-CRCNCT03693170
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
A Phase 2 study testing encorafenib, Binimetinib and Cetuximab in people with BRAF V600E-mutant Metastatic Colorectal Cancer, run by Pierre Fabre Medicament at 45 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF V600E-mutant Metastatic Colorectal Cancer
- What is being tested?
- encorafenib, Binimetinib and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 45 sitesin 9 countries
- Study dates
- 17 Jan 2019to 27 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Subject able to receive cetuximab as per approved label with regards to RAS status
- Eastern Cooperative Oncology Group Status (ECOG) 0 or 1
- Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol
- Subject able to take oral medications
Who cannot join
- 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
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.
- Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start
Show all 9Show fewer
- History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
- Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
- Known contraindication to cetuximab administration as per SPC/approved label
Trial locations and contacts
45 sites in 9 countries.
45 sites in 9 countries
Spain12 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínic I Provincial de Barcelona
Barcelona, 08036
Institut Català d'Oncologia (ICO L'Hospitalet)
Barcelona, 08908
Hospital de la Santa Creu i Santa Pau
Barcelona
Hospital Puerta de Hierro
Madrid, Madrid, 28220
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario HM Sanchinarro
Madrid, 28050
Complejo Hospitalario De Navarra S Oncologia Medica
Pamplona, Navarre, 31008
Hospital Clínico Universitario de
Valencia, 46010
Hospital Universitario y Politécnico La FE
Valencia, 46026
Hospital Alvaro Cunqueiro
Vigo, 36312
Hospital Universitario Miguel Servet
Zaragoza, 50009
France9 sites
Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie
Brest, 29200
AP-HM CHU Timone
Marseille, 13005
ICM- VAL d 'Aurelle
Montpellier, Cedex 5, 34298
Hôpital Cochin Gastroenterology
Paris, 75014
Hôpital Europeen Georges Pompidou
Paris, 75015
Hôpital Saint Antoine
Paris, 75571
HOPITAL HAUT-LEVEQUE, Av de MAGELLAN
Pessac, 33604
ICO- Site René Gauducheau
Saint-Herblain, 44805
CHU TOULOUSE Rangueil
Toulouse
Japan6 sites
Pierre Fabre Investigative Site
Fukuoka, Fukuoka, 811-1395
Pierre Fabre Investigative Site
Kashiwa, Chiba, 277-8577
Pierre Fabre Investigative Site
Koto-ku,, Tokyo, 135-8550
Pierre Fabre Investigative Site
Nagaizumi-cho, Shizuoka, 411-8777
Pierre Fabre Investigative Site
Nagoya, Aichi-ken, 464-8681
Pierre Fabre Investigative Site
Osaka, Osaka, 540-0006
United Kingdom6 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
St James Hospital
Leeds, LS9 7TF
GI research team, OHCT, Guy's Hospital
London, SE1 9RT
GI Research Team, The Christie NHS Foundation Trust
Manchester, M20 4BX
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Torbay Hospital, Lowes Bridge
Torquay, Devon, TQ2 7AA
Italy5 sites
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, 10060
Ospedale Policlinic San Martin
Genova, 16132
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola, Forlì-Cesena, 47014
Ospedale S.M. Misericordia
Perugia, 06129
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
Belgium3 sites
Cliniques universitaires Saint-Luc
Brussels, 1200
UZ Gent, Gastro-Enterology
Ghent, East Flanders, 9000
Trial DIO, UZ Gasthuisberg
Leuven, Flemish Brabant, 3000
United States2 sites
PC dba West Cancer Center
Germantown, Tennessee, 38138
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer
The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.
Read the detailed description
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.
- Being tested
- encorafenib, Binimetinib, Cetuximab
- Keywords
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
encorafenibDrug
Also called Braftovi
300 mg administered orally once daily (QD)
BinimetinibDrug
Also called Mektovi
Binimetinib 45 mg administered orally twice daily (BID)
CetuximabDrug
Also called Erbitux
Standard of care for the 28 first weeks(*) and then every 2 weeks (**) :
(*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (**) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward.
Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| 1 Arm | Experimental | encorafenib plus binimetinib plus cetuximab Receives: Drug: encorafenib; Drug: Binimetinib; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments
The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Measured: From initiation of treatment to disease progression up to a maximum of 17.6 months.
Secondary outcomes (13)
Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment
The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Measured: From initiation of treatment to disease progression up to a maximum of 17.6 months
Overall Response Rate (ORR) Based on Local Tumor Assessments
The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Measured: From initiation of treatment to disease progression up to a maximum of 17.6 months
Overall Response Rate (ORR) Based on Central Tumor Assessments
The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Measured: From initiation of treatment to disease progression up to a maximum of 17.6 months
Duration of Response (DOR) Per Local Assessment
Time from first radiographic evidence of response based on local radiologist/investigator review to the earliest documented PD or death due to underlying disease
Measured: From first radiographic evidence of response to disease progression up to a maximum of 17.6 months
Duration of Response (DOR) Per Central Assessment
Time from first radiographic evidence of response based on central review to the earliest documented PD or death due to underlying disease
Measured: From first radiographic evidence of response to disease progression up to a maximum of 17.6 months
Time to Response (TTR) Per Local Review
The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per local review
Measured: From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months
Time to Response (TTR) Per Central Review
The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per central review
Measured: From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months
Progression-Free Survival (PFS) Per Local Review
Time from first dose to the earliest documented date of disease progression based on local radiologist/investigator review or death due to any cause
Measured: From initiation of treatment to disease progression or death up to a maximum of 17.6 months
Progression of Free Survival (PFS) Per Central Review
Time from first dose to the earliest documented date of disease progression based on central review or death due to any cause
Measured: From initiation of treatment to disease progression or death up to a maximum of 17.6 months
Overall Survival (OS)
Time from first dose to death due to any cause
Measured: From initiation of treatment to death up to a maximum of 17.6 months
Change From Baseline in EORTC QLQ-C30 Over Time
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer subjects (EORTC QLQ-C30) includes a global health status/QoL. The scale ranges in score from 0 to 100, higher score on the global health status/QoL scale indicate higher QoL.
Changes from baseline in EORTC QLQ-C30 global health status/quality of life (QoL) over time are presented in this record.
Measured: From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months
Change From Baseline in EQ-5D-5L Over Time
The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L VAS records the patient's self-rated health on a vertical visual analogue scale numbered from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). Changes from baseline in EQ-5D-5L VAS over time are presented in this record.
Measured: From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months
PGIC Scores Over Time
The Patient Global Impression of Change (PGIC) is a measure of patients' perceptions of change in their symptoms over time. For this assessment, subjects answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse."
Measured: From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start17 Jan 2019
- Primary completion29 Jun 2020
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BRAF V600E-mutant Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Isabelle KLAUCK, MD, Study director, Corporate Medical&Patient/Consumer Division, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693170
- Sponsor's protocol ID
- W00090 GE 2 01
- Acronym
- ANCHOR-CRC
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2018
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Van Cutsem E, Taieb J, Yaeger R, Yoshino T, Grothey A, Maiello E, Elez E, Dekervel J, Ross P, Ruiz-Casado A, Graham J, Kato T, Ruffinelli JC, Andre T, Carriere Roussel E, Klauck I, Groc M, Vedovato JC, Tabernero J. ANCHOR CRC: Results From a Single-Arm, Phase II Study of Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer. J Clin Oncol. 2023 May 10;41(14):2628-2637. doi: 10.1200/JCO.22.01693. Epub 2023 Feb 10.
PubMed 36763936
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03693170
- Acronym / sponsor ID
- ANCHOR-CRC / W00090 GE 2 01
- Keywords
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, Merck KGaA, Darmstadt, Germany
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 30 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Arm | Experimental | Drug: encorafenib, Drug: Binimetinib, Drug: Cetuximabencorafenib plus binimetinib plus cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Subject able to receive cetuximab as per approved label with regards to RAS status
Key exclusion criteria (9 listed)
- 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
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| encorafenibAlso: Braftovi300 mg administered orally once daily (QD) | Drug | 1 Arm |
| BinimetinibAlso: MektoviBinimetinib 45 mg administered orally twice daily (BID) | Drug | 1 Arm |
| CetuximabAlso: ErbituxStandard of care for the 28 first weeks(*) and then every 2 weeks (**) : (*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (**) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward. Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic. | Drug | 1 Arm |
Primary outcome
Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments
Time frame: From initiation of treatment to disease progression up to a maximum of 17.6 months.
The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
13 secondary outcomes
Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment
Time frame: From initiation of treatment to disease progression up to a maximum of 17.6 months
Overall Response Rate (ORR) Based on Local Tumor Assessments
Time frame: From initiation of treatment to disease progression up to a maximum of 17.6 months
Overall Response Rate (ORR) Based on Central Tumor Assessments
Time frame: From initiation of treatment to disease progression up to a maximum of 17.6 months
Duration of Response (DOR) Per Local Assessment
Time frame: From first radiographic evidence of response to disease progression up to a maximum of 17.6 months
Duration of Response (DOR) Per Central Assessment
Time frame: From first radiographic evidence of response to disease progression up to a maximum of 17.6 months
Time to Response (TTR) Per Local Review
Time frame: From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months
Time to Response (TTR) Per Central Review
Time frame: From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months
Progression-Free Survival (PFS) Per Local Review
Time frame: From initiation of treatment to disease progression or death up to a maximum of 17.6 months
Progression of Free Survival (PFS) Per Central Review
Time frame: From initiation of treatment to disease progression or death up to a maximum of 17.6 months
Overall Survival (OS)
Time frame: From initiation of treatment to death up to a maximum of 17.6 months
Change From Baseline in EORTC QLQ-C30 Over Time
Time frame: From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months
Change From Baseline in EQ-5D-5L Over Time
Time frame: From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months
PGIC Scores Over Time
Time frame: From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36763936Van Cutsem E, Taieb J, Yaeger R, Yoshino T, Grothey A, Maiello E, Elez E, Dekervel J, Ross P, Ruiz-Casado A, Graham J, Kato T, Ruffinelli JC, Andre T, Carriere Roussel E, Klauck I, Groc M, Vedovato JC, Tabernero J. ANCHOR CRC: Results From a Single-Arm, Phase II Study of Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer. J Clin Oncol. 2023 May 10;41(14):2628-2637. doi: 10.1200/JCO.22.01693. Epub 2023 Feb 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle KLAUCK, MD study director
Corporate Medical&Patient/Consumer Division, Pierre Fabre Medicament
45 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing encorafenib, Binimetinib and Cetuximab in people with BRAF V600E-mutant Metastatic Colorectal Cancer, run by Pierre Fabre Medicament at 45 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Spain, France, Japan, United Kingdom, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments (time frame: From initiation of treatment to disease progression up to a maximum of 17.6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.