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Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation

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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 skin cancer called melanoma, specifically when it has spread to other parts of the body or cannot be removed by surgery. The study is looking at patients with a specific genetic change known as the BRAF V600E/K mutation. The trial will test the effectiveness of a combination of medications: Encorafenib, Binimetinib, and Pembrolizumab. Encorafenib is taken as a capsule, Binimetinib as a tablet, and Pembrolizumab is given through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to compare the effects of the combination of Encorafenib, Binimetinib, and Pembrolizumab against a placebo combined with Pembrolizumab. Participants will be randomly assigned to receive either the combination of the three medications or the placebo with Pembrolizumab. The study will last for up to 24 months, during which participants will receive regular treatments and check-ups to monitor their health and the progress of the melanoma.

This trial aims to determine if the combination of these medications can improve outcomes for patients with this specific type of melanoma. The study will also assess the safety of the medication combination and monitor any side effects that may occur. Participants will be closely observed by healthcare professionals throughout the study to ensure their well-being and to gather important information about the treatment's effectiveness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of melanoma, and genetic mutation status.

    Adequate tumor tissue must be submitted for laboratory testing to confirm the presence of the BRAF V600E or V600K mutation.

  2. Step 2

    Safety lead-in phase

    During this phase, the main goal is to determine the recommended dose of encorafenib and binimetinib when combined with pembrolizumab.

    Participants may receive encorafenib and binimetinib orally, along with pembrolizumab administered intravenously.

  3. Step 3

    Randomized phase 3

    Participants are randomly assigned to one of two groups: the triplet arm or the control arm.

    The triplet arm receives encorafenib, binimetinib, and pembrolizumab, while the control arm receives a placebo with pembrolizumab.

    The effectiveness of the treatment is compared between the two groups.

  4. Step 4

    Treatment administration

    Encorafenib and binimetinib are taken orally, while pembrolizumab is given as an intravenous infusion.

    The dosage and frequency of administration are determined based on the safety lead-in phase results.

  5. Step 5

    Monitoring and assessments

    Regular monitoring of health status, including vital signs and laboratory tests, is conducted to assess safety and effectiveness.

    Imaging tests are performed to evaluate the response of the melanoma to the treatment.

  6. Step 6

    End of study participation

    Participation in the study concludes upon completion of the treatment period or if the disease progresses.

    Final assessments are conducted to gather data on the overall outcomes of the treatment.

Who can join the trial?

8 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants must have a type of skin cancer called melanoma that is either not removable by surgery or has spread to other parts of the body. This must be confirmed by a test called a histological test.
  • Participants must have a specific change in their cancer cells called a BRAF V600E or V600K mutation.
  • Participants need to provide a sample of their tumor for testing to confirm the presence of the BRAF V600E/K mutation.
  • For the Safety Lead-In part of the study, participants should not have received more than one previous treatment for their melanoma that has spread or cannot be removed by surgery.
  • For the Phase 3 part of the study, participants should not have received any previous treatment for their melanoma that has spread or cannot be removed by surgery.
  • Participants must have at least one tumor that can be measured using a specific guideline called RECIST v1.1.
  • Participants must have a good general health status, which is measured by a scale called ECOG Performance Status, and should have a score of 0 or 1. They must also have healthy organs and heart function, with a heart test showing a Left Ventricular Ejection Fraction (LVEF) of 50% or higher.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have had a different treatment for their cancer recently.
  • Patients with serious heart problems.
  • Patients with serious liver or kidney problems.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an infection that is not well controlled.
  • Patients who have a history of another serious illness that could affect the study.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Encorafenib

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

  • Binimetinib

    is another medication used in combination with encorafenib. It targets a different protein in the cancer cell growth pathway, which helps to enhance the effect of encorafenib and further inhibit the growth of melanoma cells.

  • Pembrolizumab

    is an immunotherapy drug used in this trial. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab blocks a specific protein that prevents the immune system from attacking the cancer, thereby boosting the body's natural defenses against the melanoma.

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 melanoma with specific genetic mutations. It is primarily used for patients with metastatic or locally advanced melanoma that cannot be surgically removed and has a BRAF V600E/K mutation. Encorafenib works by inhibiting the BRAF protein, 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.

  • Binimetinib

    This medication is taken orally and is under investigation in clinical trials for its role in treating certain types of melanoma. It is used in combination with other drugs for patients with BRAF V600E/K mutation-positive melanoma that is either metastatic or cannot be surgically removed. Binimetinib functions by inhibiting the MEK proteins, which are part of a pathway that promotes cancer cell growth. It belongs to the class of MEK inhibitors.

  • Pembrolizumab

    Administered through intravenous infusion, this medication is widely recognized in medical literature and is approved for use in various cancers, including melanoma. It is used to treat patients with advanced melanoma, often in combination with other drugs. Pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Metastatic or unresectable locally advanced BRAF V600E/K mutation positive melanoma – This is a type of skin cancer that has spread to other parts of the body or cannot be surgically removed. It is characterized by a specific mutation in the BRAF gene, known as V600E or V600K. This mutation leads to uncontrolled cell growth and division, contributing to the progression of melanoma. The disease often begins as a change in the appearance of a mole or a new skin growth. Over time, it can invade nearby tissues and spread to distant organs. The progression of this melanoma can vary, but it typically involves the development of new tumors in other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512038-13-00Protocol codeC4221016Estimated enrolment228 patientsSponsorPfizer Inc.

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