Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New cocktail shows promise against Tough-to-Treat colon cancer

NCT ID NCT03693170

Disease control Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 4 times

Summary

This phase 2 trial tested a combination of three drugs—encorafenib, binimetinib, and cetuximab—in 95 patients with a specific type of advanced colorectal cancer (BRAF V600E mutation) who had not received prior treatment for their metastatic disease. The goal was to see how many patients' tumors shrank or disappeared. Results showed that the combination was effective in many patients, offering a potential new first-line option for this hard-to-treat cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
encorafenib, binimetinib, and cetuximab
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with this specific type of advanced colorectal cancer, potentially shrinking tumors and delaying progression.
What could go wrong
This is a phase 2 trial with only 95 participants and no comparison group, so results are preliminary. The combination may cause significant side effects, and not all patients will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

95 people

The number who actually took part.

Started

Jan 2019

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for BRAF V600E-mutant metastatic colorectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRAF V600E-mutant metastatic colorectal cancer

Contacts and locations

Locations

  • AP-HM CHU Timone

    Marseille, 13005, France

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • CHU TOULOUSE Rangueil

    Toulouse, France

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario De Navarra S Oncologia Medica

    Pamplona, Navarre, 31008, Spain

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, 10060, Italy

  • GI Research Team, The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • GI research team, OHCT, Guy's Hospital

    London, SE1 9RT, United Kingdom

  • HOPITAL HAUT-LEVEQUE, Av de MAGELLAN

    Pessac, 33604, France

  • Hospital Alvaro Cunqueiro

    Vigo, 36312, Spain

  • Hospital Clínic I Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario de

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009, Spain

  • Hospital Puerta de Hierro

    Madrid, Madrid, 28220, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario y Politécnico La FE

    Valencia, 46026, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Santa Pau

    Barcelona, Spain

  • Hôpital Cochin Gastroenterology

    Paris, 75014, France

  • Hôpital Europeen Georges Pompidou

    Paris, 75015, France

  • Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie

    Brest, 29200, France

  • Hôpital Saint Antoine

    Paris, 75571, France

  • ICM- VAL d 'Aurelle

    Montpellier, Cedex 5, 34298, France

  • ICO- Site René Gauducheau

    Saint-Herblain, 44805, France

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013, Italy

  • Institut Català d'Oncologia (ICO L'Hospitalet)

    Barcelona, 08908, Spain

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola, Forlì-Cesena, 47014, Italy

  • Krankenhaus der Barmherzigen Brüder

    Vienna, 1020, Austria

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Ospedale Policlinic San Martin

    Genova, 16132, Italy

  • Ospedale S.M. Misericordia

    Perugia, 06129, Italy

  • PC dba West Cancer Center

    Germantown, Tennessee, 38138, United States

  • Pierre Fabre Investigative Site

    Nagoya, Aichi-ken, 464-8681, Japan

  • Pierre Fabre Investigative Site

    Kashiwa, Chiba, 277-8577, Japan

  • Pierre Fabre Investigative Site

    Fukuoka, Fukuoka, 811-1395, Japan

  • Pierre Fabre Investigative Site

    Osaka, Osaka, 540-0006, Japan

  • Pierre Fabre Investigative Site

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • Pierre Fabre Investigative Site

    Koto-ku,, Tokyo, 135-8550, Japan

  • St Antonius Ziekenhuis

    Utrecht, 3543 AZ, Netherlands

  • St James Hospital

    Leeds, LS9 7TF, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Torbay Hospital, Lowes Bridge

    Torquay, Devon, TQ2 7AA, United Kingdom

  • Trial DIO, UZ Gasthuisberg

    Leuven, Flemish Brabant, 3000, Belgium

  • UZ Gent, Gastro-Enterology

    Ghent, East Flanders, 9000, Belgium