Study Comparing Encorafenib, Binimetinib, and Nivolumab with Ipilimumab and Nivolumab for Melanoma with Brain Metastases

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04511013

Provider View

This clinical trial is testing two different treatment combinations to see which is more effective in treating melanoma that has spread to the brain. The study compares the effects of encorafenib, binimetinib, and nivolumab against ipilimumab and nivolumab in shrinking and controlling brain tumors in patients with a specific BRAF-V600 mutation.

Patient Parameters

Program Overview

The purpose of this study is to compare two treatment combinations for melanoma that has spread to the brain. One group will receive encorafenib, binimetinib, and nivolumab, while the other group will receive ipilimumab and nivolumab. The study aims to find out which combination is better at stopping the growth of brain tumors in patients with a BRAF-V600 mutation.

Description

The main goal of this study is to see which treatment combination helps patients live longer without their cancer getting worse. Researchers will compare the effects of encorafenib, binimetinib, and nivolumab with ipilimumab and nivolumab in patients with melanoma that has spread to the brain.

Secondary goals include:

  • Estimating how long patients live overall with each treatment.
  • Measuring how well the tumors respond to each treatment.
  • Evaluating how long the response to treatment lasts.
  • Checking the safety and side effects of each treatment.
  • Collecting tumor tissue, spinal fluid, stool, and blood samples for future research.

Participants will be randomly assigned to one of two groups:

  • Group 1 will take encorafenib and binimetinib pills daily and receive nivolumab through an IV every 28 days.
  • Group 2 will receive nivolumab through an IV every 28 days and ipilimumab through an IV every 21 days for the first four cycles, then every 28 days.

After finishing the treatment, participants will have follow-up visits every six months for two years, then once a year for another year.

Eligibility Criteria

Inclusion Criteria

  • Must have melanoma that has spread to the brain, confirmed by medical tests.
  • Must have a specific BRAF-V600 mutation in their melanoma.
  • Must have had an MRI scan of the brain within 28 days before joining the study, showing at least one brain tumor that is 0.5 cm or larger and has not been treated with radiation.
  • May have other tumors outside the brain, but it's not required.
  • May be taking up to 8 mg of dexamethasone daily for brain tumors.
  • Must be able to swallow pills.
  • Must have certain blood counts and organ function within normal limits.
  • Must not have serious heart problems.
  • Must agree to participate in image and specimen collection for research.
  • Must sign an informed consent form.

Exclusion Criteria

  • Must not have received previous treatment for metastatic melanoma, except in certain early-stage settings.
  • Must not have had radiation therapy within 7 days before joining the study.
  • Must not plan to use hormonal contraceptives during the study.
  • Must not have a serious infection requiring treatment at the time of joining the study.
  • Must not have active autoimmune diseases needing treatment in the past 6 months.
  • Must not have had severe side effects from similar treatments in the past.
  • Must not be pregnant or breastfeeding, and must agree to use effective contraception if of reproductive potential.

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