Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Comparing a standard dose with a high dose of encorafenib plus binimetinib in people with melanoma that has spread to the brain

Date of summary: September 2019

Study number: NCT03911869

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Study start date: June 2019

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Estimated study end date: October 2022

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The full title of this abstract is: A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis (MBM) (POLARIS)

This study drug is approved to treat the condition
under study that is discussed in this summary.

 

Researchers must look at the results of many types of
studies to understand whether a study drug works,
how it works, and whether it is safe to prescribe to
patients.

More information can be found in the scientific
abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Melanoma is a type of skin cancer. Melanoma usually starts in the cells that give the skin its color. These cells are called melanocytes.
    • Sometimes melanoma develops in melanocytes in other parts of the body, such as the eyes and intestines.
  • Melanoma can spread from where it started to other parts of the body.
    • When this cancer spreads to the brain, it is called melanoma brain metastasis.
  • Some people with melanoma have a faulty gene called BRAF. Faulty BRAF genes make altered versions of the BRAF protein, which helps cancer cells to grow.
    • Encorafenib blocks activity of the BRAF protein.
  • Melanoma cells may have changes in other proteins too. MEK proteins go into action when BRAF proteins are altered and they help cancer cells to grow also.
    • Binimetinib blocks the activity of MEK proteins.
  • Encorafenib plus binimetinib is approved in Europe for the treatment of melanoma that:
    • has a faulty BRAF gene and cannot be removed by surgery, or
    • has spread to other parts of the body.
  • Encorafenib plus binimetinib is approved for the treatment of melanoma that:
    • has a faulty BRAF gene and cannot be removed by surgery, or
    • has spread to other parts of the body.
  • This study is called POLARIS. People will be followed for more than 3 years. POLARIS will look at the effects of encorafenib plus binimetinib in people with melanoma that has faulty BRAF genes and has spread to the brain in two different ways
    1. 1. Using the standard dose of encorafenib (taken once each day)
    2. 2. Using a high dose of encorafenib (a total of 1.5 times the standard dose, taken twice per day)
  • The summary covers the planned design for this upcoming study.

Who will take part in this study?

  • In terms of previous treatment, everyone will have had at least 1 previous treatment for melanoma.
    • People may have already received a type of treatment called a checkpoint inhibitor.
      • Checkpoint inhibitors help the body’s immune system to destroy cancer cells.
    • People may have already received 1 other treatment before their cancer spread that can block altered BRAF and MEK proteins.
    • Nobody will have had previous treatment for melanoma brain metastases.
  • People will be split into groups based on different factors, before being placed into a study treatment group at random. These factors are:
    • How many melanoma brain metastases they have (1–2 or 3 or more)
    • Whether they have already received a checkpoint inhibitor treatment
  • This step helps to balance peoples’ characteristics between the groups.

What will this study look at?

  • Researchers will look at any medical problems that may occur with the high dose of encorafenib plus binimetinib in the first 9 people who receive this treatment in the study.
    • If these people do not tolerate the high dose, everyone else who enters the study will take the standard dose.

More results from this study can be found here:
View ESMO Scientific Abstract

  • The researchers will assess:
    • Whether people’s cancers respond to treatment.
    • Response means that the cancer disappears or shrinks.
    • How long peoples’ cancers respond to treatment.
    • How long people live with their cancer without it getting worse.
    • How long people live for overall.
    • How safe the treatments are.
    • How the treatments affect the body over a set time.
  • People who meet the entry conditions are currently joining this trial.

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the
people who took part in this study.

Array BioPharma Inc (a subsidiary of Pfizer Inc)
3200 Walnut Street
Boulder, CO 80301
Phone (United States): +1 303-381-6600

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