Study of encorafenib and cetuximab treatment for patients with BRAF V600E-mutant metastatic colorectal cancer who previously responded to BRAF inhibitor therapy

2 1 1 1

What is this study about?

This study focuses on patients with metastatic colorectal cancer who have a specific genetic change called BRAF V600E mutation. These patients have previously received and responded to treatment that included a BRAF inhibitor. The study will test a combination of two medications: encorafenib (taken by mouth) and cetuximab (given through a vein) as a retreatment option.

The purpose of this research is to determine how well this combination therapy works when given again to patients who have previously benefited from similar treatment but whose cancer has since progressed. The study will measure how long patients remain without their cancer getting worse, particularly during the first four months of treatment.

During this single-group study, all participants will receive both medications. The treatment can continue for up to 36 months, depending on how well it works and how well it is tolerated. Throughout the study, doctors will monitor patients’ health through regular medical examinations and tests to check for any side effects and to see how the treatment is working.

1 Initial medication phase

You will receive a combination of two medications: encorafenib (taken orally) and cetuximab (given intravenously)

This treatment is designed for patients with BRAF V600E-mutant metastatic colorectal cancer who have previously responded to BRAF inhibitor treatment

The treatment will be administered after at least 4 months have passed since your last BRAF inhibitor treatment

2 Regular monitoring phase

Your progress will be monitored regularly through medical examinations

The medical team will assess your condition using RECIST criteria (a standardized way to measure if tumors are responding to treatment)

Regular laboratory tests will be conducted to check your blood count, liver function, and kidney function

Your heart function will be monitored through ECG tests

Any side effects will be recorded and assessed using standardized criteria

3 Four-month assessment

At the 4-month mark, a detailed assessment will be conducted to evaluate how well the treatment is working

This evaluation will include imaging tests to check if the cancer has progressed

The medical team will determine if the treatment should continue based on your response

4 Ongoing treatment phase

Treatment will continue as long as you are responding positively and not experiencing severe side effects

Regular assessments will continue throughout the treatment period

The study is planned to continue until May 2029

Who Can Join the Study?

  • Must be 18 years or older
  • Must provide signed and dated informed consent form
  • Must have confirmed metastatic colorectal cancer (cancer that has spread from colon to other parts of body)
  • Must have confirmed BRAF V600E mutation (specific genetic change in tumor)
  • Must be able to take oral medications
  • Must have a good performance status (ECOG 0-1), meaning able to perform daily activities with minimal assistance
  • Must have adequate bone marrow function, including:
    – Sufficient white blood cells
    – Sufficient platelets
    – Sufficient hemoglobin levels
  • Must have proper liver and kidney function based on blood test results
  • Must have adequate heart function
  • Must have previously received at least 2 different treatment regimens for metastatic disease
  • Must have previously received and responded to treatment containing BRAF inhibitor for at least 4 months
  • Must have at least 4 months break since last BRAF inhibitor treatment
  • Must have measurable disease that can be evaluated by scans
  • Must have life expectancy of more than 12 weeks
  • Must use effective contraception during study and for 2 months after last study medication if able to conceive

Who Cannot Join the Study?

  • Prior treatment with encorafenib or cetuximab (these are medications used in cancer treatment)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
  • Major surgery within 4 weeks before starting the study treatment
  • Serious or uncontrolled medical conditions that could interfere with study participation
  • Known allergies or severe reactions to the study medications or their components
  • Pregnancy or breastfeeding
  • Active, uncontrolled infections
  • Heart problems including:
    • Unstable angina (chest pain)
    • Heart attack within the past 6 months
    • Uncontrolled high blood pressure
  • Participation in another clinical trial within 4 weeks before starting this study
  • Any condition that would make the patient unable to comply with study requirements or follow-up visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hdvgtdnu Vjds ddlbtcoz Barcelona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.07.2025

Trial locations

Investigated drugs:

Encorafenib is a targeted therapy medication that works by blocking a specific protein called BRAF when it has a certain mutation (V600E). This medication helps slow down or stop the growth of cancer cells in colorectal cancer that has this specific genetic change.

Cetuximab is a type of medication called a monoclonal antibody. It works by targeting a protein called EGFR (epidermal growth factor receptor) that is found on the surface of cancer cells. By blocking this protein, cetuximab helps prevent cancer cells from growing and spreading. It is given through an intravenous infusion.

These medications are used together as a combination therapy for patients with colorectal cancer that has spread to other parts of the body (metastatic), specifically in cases where the cancer has a BRAF V600E mutation and the patient has previously responded to similar treatments.

Metastatic Colorectal Cancer (mCRC) with BRAF V600E mutation – A form of advanced colorectal cancer where cancer cells have spread beyond the original site to other parts of the body. This specific type is characterized by a mutation in the BRAF gene called V600E, which affects how cancer cells grow and divide. The disease begins in the colon or rectum and develops when healthy cells acquire this particular genetic mutation, leading to uncontrolled cell growth. As the disease progresses, cancer cells can break away from the primary tumor and travel through the blood or lymphatic system to form new tumors in other organs.

Trial ID:
2023-509564-22-00
Protocol code:
VHIO23004
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study of Ivonescimab Combined with Fluorouracil, Folinic Acid, and Oxaliplatin Compared to Bevacizumab for Patients with Metastatic Colorectal Cancer

    Recruiting

    3 1 1 1
    Belgium Czechia France Germany Hungary Italy +2
  • Study of FOLFOX or FOLFIRI chemotherapy with fruquintinib or bevacizumab as second-line treatment for patients with metastatic colorectal cancer

    Recruiting

    2 1 1 1
    France