Study on Binimetinib and Encorafenib for Treating Metastatic Melanoma with Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05026983

Provider View

This clinical trial is exploring the effects of two drugs, binimetinib and encorafenib, on melanoma that has spread to the brain. These drugs may help stop tumor growth by blocking certain enzymes needed for cancer cells to grow.

Patient Parameters

Program Overview

This phase II study is testing whether the combination of binimetinib and encorafenib can help control melanoma that has spread to the brain or central nervous system. These drugs work by blocking enzymes that cancer cells need to grow. The study aims to see if this treatment can stop the cancer from getting worse and to evaluate its safety for patients.

Description

The main goals of this study are to see how well the combination of encorafenib and binimetinib works in stopping the growth of melanoma that has spread to the brain and to check if the treatment is safe for patients. Researchers will measure how long patients live without the cancer getting worse and how the cancer responds to the treatment.

The study will also look at how the treatment affects immune cells in the brain and blood, and how it impacts patients' cognitive functions.

Participants will take encorafenib once a day and binimetinib twice a day in 28-day cycles, as long as the cancer does not progress or cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits 30 days later and then every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written consent to participate.
  • Aged 18 years or older.
  • Have a confirmed diagnosis of melanoma.
  • Have a specific mutation (BRAFV600) in the tumor.
  • For Cohort A: Must have melanoma with brain metastases and have previously been treated with BRAF inhibitors.
  • For Cohort B: Must have melanoma with brain metastases and have not been treated with BRAF/MEK inhibitors.
  • Must have at least one measurable brain tumor.
  • Must have a performance status score of 2 or less, indicating ability to carry out daily activities.
  • May use steroids to manage symptoms related to brain involvement.
  • Prior radiation therapy is allowed if the cancer is progressing.
  • Must have adequate blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.
  • Men must agree to use contraception and not donate sperm during the study.

Exclusion Criteria

  • Active infection within 7 days before starting the study.
  • Use of live vaccines within 30 days before starting the study.
  • Inability to swallow the study medication.
  • History of HIV or AIDS.
  • Significant heart disease or abnormal heart rhythms.
  • Neuromuscular disorders.
  • Digestive issues that affect medication absorption.
  • History of eye conditions like retinal vein occlusion.
  • Use of certain herbal supplements or medications that affect drug metabolism.
  • Recent history of blood clots.
  • Active hepatitis B or C infection.
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study.
  • Other severe medical or psychiatric conditions that could interfere with the study.

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