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Study of Encorafenib, Cetuximab, and Pembrolizumab for Patients with Untreated BRAF V600E-Mutant Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic colorectal cancer, which has specific characteristics known as BRAF V600E mutation and MSI-H/dMMR. These terms refer to genetic changes in the cancer cells that can affect how the cancer grows and responds to treatment. The study is testing a combination of medications to see how effective they are in treating this type of cancer. The medications being studied are Encorafenib, Cetuximab, and Pembrolizumab. Encorafenib is taken as a capsule, while Cetuximab and Pembrolizumab are given through an injection into a vein.

The purpose of the study is to compare the effectiveness of using Encorafenib and Cetuximab together with Pembrolizumab against using Pembrolizumab alone. Participants in the study will be randomly assigned to one of these two treatment groups. The study will last for up to 24 months, during which participants will receive their assigned treatment and have regular check-ups to monitor their health and the cancer’s response to the treatment.

Throughout the study, participants will have regular visits with the study team to assess their health, including blood tests and scans to check the cancer’s progress. The study aims to provide valuable information on whether the combination of these medications can offer better outcomes for patients with this specific type of metastatic colorectal cancer. The results could help improve treatment options for future patients with similar conditions.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives a combination of medications, while the other group receives a single medication.

2 treatment administration

Participants in the combination group receive encorafenib orally, cetuximab intravenously, and pembrolizumab intravenously. The specific dosage and frequency are determined by the study protocol.

Participants in the single medication group receive pembrolizumab intravenously. The specific dosage and frequency are determined by the study protocol.

3 monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This includes clinical laboratory tests, vital signs, and ECGs.

Participants’ health status and quality of life are evaluated using specific questionnaires and scales.

4 follow-up

After completing the treatment phase, participants continue to be monitored for a period to assess long-term outcomes and any delayed side effects.

Who Can Join the Study?

  • The patient must have a specific type of cancer called MSI-H/dMMR metastatic colorectal cancer. This means the cancer has certain genetic features.
  • The patient must have a confirmed BRAF V600E mutation in their tumor. This is a specific change in the cancer’s genes.
  • The patient must be at least 16 years old. In some places, the minimum age is 18.
  • The patient must be able to understand and sign a consent form, or have a legal guardian who can do so.
  • The patient must be willing to follow all the study’s rules and attend all scheduled visits and tests.
  • The patient must have a confirmed diagnosis of metastatic Stage IV colorectal adenocarcinoma, which is a type of advanced colon cancer.
  • The patient must have measurable disease, meaning the cancer can be seen and measured on scans.
  • The patient must provide a sample of their tumor tissue for testing.
  • The patient must not have received any previous treatments specifically for metastatic disease.
  • The patient must have a good general health status, as measured by a test called the ECOG performance status, which should be 0 or 1. This means the patient is fully active or has some symptoms but can still do light work.
  • The patient must have adequate bone marrow function, which means their blood counts are at a healthy level.
  • The patient must have adequate liver and kidney function, meaning their liver and kidneys are working well enough.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than metastatic colorectal cancer with MSI-H/dMMR. Metastatic means the cancer has spread to other parts of the body. MSI-H/dMMR refers to specific genetic features of the cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have had certain treatments for cancer recently, which might affect the study results.
  • Patients who have allergies to the study medications.
  • Patients who have an active infection or other medical condition that could affect their safety during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hopital Saint Antoine Paris France
Institut Jules Bordet Anderlecht Belgium
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Fondazione Poliambulanza Brescia Italy
Skaraborg Hospital-Vaestra Goetalandsregionen Skovde Sweden
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Narodny Onkologicky Ustav Bratislava Slovakia
Universita’ Di Pisa Pisa Italy
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Aalborg University Hospital Aalborg Denmark
Rigshospitalet Copenhagen Denmark
Hopital Beaujon Clichy France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Fakultni Thomayerova nemocnice Prague Czechia
Soedersjukhuset AB Stockholm Sweden
Cgsxvgccd Udrgdptzgasrqb Sytxmzlbg Woluwe-Saint-Lambert Belgium
Irghombz Rbwwpnun Df Cktjpz Ds Mpmwoqsfdok Montpellier France
Iueoupfg Cqbwku Dlssikyxodauuwhjm L'hospitalet De Llobregat Spain
Iokoph Bonheiden Belgium
Ahjilrk Uth Tbocbaf ncri otmzz Leghorn Italy
Pdynjeazdnb Lxfqerwp &vardqzdysskyocpnzeg Ryikm Kxjfpfpfknz Konin Poland
Hlmdpc Hfncyiat Herlev Denmark
Aahebgv Ukx Ieuch Dp Rtkuzp Efolzg Reggio Emilia Italy
Hvvoplnk Vdpa ddhpkvmb 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
11.07.2022
Czechia Czechia
Not recruiting
11.07.2022
Denmark Denmark
Not recruiting
11.07.2022
France France
Not recruiting
11.07.2022
Germany Germany
Not recruiting
11.07.2022
Italy Italy
Not recruiting
11.07.2022
Norway Norway
Not recruiting
11.07.2022
Poland Poland
Not recruiting
11.07.2022
Slovakia Slovakia
Not recruiting
11.07.2022
Spain Spain
Not recruiting
11.07.2022
Sweden Sweden
Not recruiting
11.07.2022
The Netherlands The Netherlands
Not recruiting
11.07.2022

Trial locations

Investigated drugs:

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

Cetuximab is a therapy that targets and binds to a protein on the surface of cancer cells called EGFR. By doing this, it helps to prevent the cancer cells from growing and dividing. It is used in combination with other medications to enhance its effectiveness.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It works by blocking a specific pathway that cancer cells use to hide from the immune system, allowing the body’s natural defenses to better target and destroy the cancer.

Investigated diseases:

Metastatic Colorectal Cancer with MSI-H/dMMR – This type of colorectal cancer is characterized by the presence of high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) in the tumor cells. These genetic features can lead to a higher number of mutations within the cancer cells. The disease typically begins in the colon or rectum and can spread to other parts of the body, such as the liver or lungs. As the cancer progresses, it may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. The presence of MSI-H/dMMR can influence the behavior of the cancer and its response to certain treatments.

Trial ID:
2024-512119-34-00
Protocol code:
C4221022
Trial Phase:
Therapeutic exploratory (Phase II)

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