Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

9 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Encorafenib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, specifically BRAF V600E-mutant, MSI-H/dMMR metastatic colorectal cancer. It is used in combination with other drugs to enhance its therapeutic effects. Encorafenib works by inhibiting a specific protein called BRAF, which is involved in cell growth, thereby slowing down or stopping the growth of cancer cells. It is classified as a BRAF inhibitor in pharmacology.

  • Cetuximab

    Administered via intravenous infusion, cetuximab is being evaluated in clinical trials for its role in treating metastatic colorectal cancer with specific genetic mutations. It is often used in combination with other medications to improve treatment outcomes. Cetuximab targets the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking signals that promote cell division and growth. It is classified as an EGFR inhibitor.

  • Pembrolizumab

    This medication is given through intravenous infusion and is currently approved for use in various cancers, including metastatic colorectal cancer with specific genetic markers. It is being studied further in clinical trials to assess its efficacy in combination with other drugs. Pembrolizumab works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512119-34-00Protocol codeC4221022Estimated enrolment104 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.