Study for Patients with Metastatic Colorectal Cancer with BRAF V600E Mutation Using Encorafenib, Cetuximab, and Chemotherapy Combination

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What is this study about?

This clinical trial is focused on studying a type of cancer called colorectal cancer that has a specific genetic change known as the BRAF V600E mutation. The study is testing a combination of treatments to see how effective they are in treating this cancer. The main treatments being studied are encorafenib and cetuximab, which are being used together with or without additional chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to stop the growth of cancer cells. The chemotherapy drugs involved in this study include irinotecan, oxaliplatin, fluorouracil, capecitabine, and calcium folinate. Another drug, bevacizumab, may also be used in some cases.

The purpose of the study is to compare the effectiveness of these treatments against the standard care usually given to patients with this type of cancer. The study will also look at the safety and tolerability of the treatments, which means checking for any side effects and how well patients can handle the treatment. Participants in the study will receive the treatments over a period of time, and their health will be monitored closely to see how the cancer responds to the treatment.

Throughout the study, participants will be given either the new combination of treatments or the standard care, which is the usual treatment given for this type of cancer. The study aims to find out if the new combination of treatments can help improve outcomes for patients with metastatic BRAF V600E mutant colorectal cancer, which is a form of cancer that has spread to other parts of the body. The results of this study could help improve treatment options for patients with this specific type of colorectal cancer in the future.

1 joining the study

Upon joining the study, confirmation of a specific genetic mutation in the BRAF gene is required. This involves testing tumor tissue or blood samples to ensure eligibility.

Participants must have a confirmed diagnosis of colorectal cancer with a specific genetic mutation (BRAF V600E).

2 safety lead-in phase

The initial phase focuses on determining the safety and tolerability of the treatment combinations. This involves monitoring for any adverse effects.

Participants receive a combination of encorafenib and cetuximab with chemotherapy regimens such as mFOLFOX6 or FOLFIRI.

3 phase 3 treatment

Participants are randomly assigned to different treatment groups. One group receives encorafenib and cetuximab with mFOLFOX6, while another group receives standard care.

The effectiveness of the treatments is compared by measuring progression-free survival and overall response rates.

4 cohort 3 treatment

In this phase, participants receive encorafenib and cetuximab with FOLFIRI, or FOLFIRI with or without bevacizumab.

The focus is on comparing the effectiveness of these treatments by measuring overall response rates.

5 medication administration

Medications are administered either orally or intravenously. Encorafenib is taken orally, while cetuximab, irinotecan, oxaliplatin, and bevacizumab are given through intravenous infusion.

The specific dosage and frequency depend on the treatment regimen assigned.

6 monitoring and follow-up

Regular monitoring is conducted to assess the treatment’s effectiveness and any side effects. This includes clinical evaluations, laboratory tests, and imaging studies.

Participants are required to attend scheduled visits and comply with the treatment plan throughout the study duration.

Who Can Join the Study?

  • Participants must be male or female and at least 18 years old. In some countries, participants can be as young as 16 years old if allowed.
  • Participants must have a body weight of at least 40 kg (about 88 pounds).
  • Participants must have colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
  • Participants must have Stage IV metastatic disease, meaning the cancer has spread to other parts of the body. Those with a limited spread of cancer, called oligometastatic disease, can also join if they have measurable disease.
  • Participants must provide a tumor sample for testing. This sample can be from a previous biopsy or surgery done within the last two years.
  • Participants must be able to give informed consent, meaning they understand and agree to the study’s requirements. If under guardianship, consent from a legal guardian is needed.
  • Participants must meet all Molecular Prescreening criteria, which are specific tests done before the main study.
  • Participants must be willing and able to attend all scheduled visits and follow the study’s treatment plan and procedures.
  • Participants must have a BRAF V600E mutation in their tumor tissue or blood. This is a specific change in the cancer cells that the study is focusing on.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not recovered from previous treatments or surgeries.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that need treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer in the past, unless it was treated and is not active now.
  • Patients who are taking certain medications that might interfere with the study treatment.
  • Patients with known allergies to the study drugs.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain mental health conditions that might affect their ability to participate.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have had a major surgery recently.
  • Patients with certain blood disorders.
  • Patients with severe liver or kidney problems.
  • Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Grand Hopital De Charleroi Charleroi Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Oulu University Hospital Oulu Finland
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Onkologicky Ustav Sv Alzbety s.r.o. Bratislava Slovakia
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Mbal Za Zhensko Zdrave Nadezhda OOD Sofia Bulgaria
Sørlandet sykehus Kristiansand Kristiansand Norway
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Turku University Hospital Turku Finland
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Hospital General Universitario De Valencia Valencia Spain
Aalborg University Hospital Aalborg Denmark
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Gasthuiszusters Antwerpen Antwerp Belgium
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Bytom Poland
Muenchen Klinik gGmbH Munich Germany
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Netherlands Cancer Institute Amsterdam The Netherlands
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin Germany
Cbwdummbh Uycztteydfjory Sdgmtduhw Woluwe-Saint-Lambert Belgium
Pgkk Pmdrxw scoxok Poprad Slovakia
Nqyefvdq Oprusopz Iwuucezks Bratislava Slovakia
Iioaahjv Clqclv Drwtqbfxumgdiixri L'hospitalet De Llobregat Spain
Pirrxcajrgq Loggiywg &yetzbmqwfvlintckhjl Rakim Kydsqtjepob Konin Poland
Hzvkjb Hqrdcmbq Herlev Denmark
Uvfndqj Uehulqpitm Hncvwiix Uppsala Sweden
Hreqnruk Ufupjvvmpl Cgiwxea Hhtfjnml Helsinki Finland
Aybystk Udx Ionrh Dn Rprhbu Eeyggm Reggio Emilia Italy
Hskatmvs Vbrk dxnolwxh Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
26.11.2020
Bulgaria Bulgaria
Not recruiting
26.11.2020
Czechia Czechia
Not recruiting
26.11.2020
Denmark Denmark
Not recruiting
26.11.2020
Finland Finland
Not recruiting
26.11.2020
Germany Germany
Not recruiting
26.11.2020
Italy Italy
Not recruiting
26.11.2020
Norway Norway
Not recruiting
26.11.2020
Poland Poland
Not recruiting
26.11.2020
Slovakia Slovakia
Not recruiting
26.11.2020
Spain Spain
Not recruiting
26.11.2020
Sweden Sweden
Not recruiting
26.11.2020
The Netherlands The Netherlands
Not recruiting
26.11.2020

Trial locations

Encorafenib is a medication used in this trial to target a specific mutation in cancer cells known as BRAF V600E. It works by blocking the activity of a protein that promotes cancer cell growth, helping to slow down or stop the progression of the cancer.

Cetuximab is a therapy that targets a protein on the surface of cancer cells called EGFR. By binding to this protein, cetuximab can help prevent the cancer cells from growing and dividing.

mFOLFOX6 is a combination chemotherapy regimen that includes several drugs working together to kill cancer cells. It is often used to treat colorectal cancer and includes medications that interfere with the DNA of cancer cells, preventing them from multiplying.

FOLFIRI is another chemotherapy regimen used in this trial. It combines different drugs to attack cancer cells in various ways, aiming to reduce the size of tumors and slow the spread of cancer.

Bevacizumab is a medication that works by inhibiting the growth of blood vessels that supply nutrients to tumors. By blocking this blood supply, bevacizumab can help starve the cancer cells and slow their growth.

Colorectal Cancer (BRAF V600E-mutant mCRC) – This is a type of cancer that begins in the colon or rectum and is characterized by a specific genetic mutation known as BRAF V600E. This mutation can lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. The disease often starts as a small growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes or other parts of the body. The presence of the BRAF V600E mutation is associated with a more aggressive form of colorectal cancer, which may influence the disease’s behavior and response to certain treatments.

Trial ID:
2023-509405-77-00
Protocol code:
C4221015
NCT ID:
NCT04607421
Trial Phase:
Therapeutic confirmatory (Phase III)

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