What is this trial studying for melanoma that has spread to the brain?

This trial is studying two treatment combinations to see which better controls brain metastases in patients with BRAF-V600 mutant melanoma. The research compares the effects of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The goal is to find out which combination more effectively slows disease progression and improves outcomes.

Who may be eligible for this melanoma clinical trial?

Adults aged 18 and older with melanoma that has spread to the brain and confirmed BRAF-V600 mutation may be eligible. Participants must be able to swallow pills and have no serious active infections. Anyone with prior systemic treatment for metastatic disease is excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this melanoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID04511013

A Randomized Phase 2 Trial Comparing Encorafenib Binimetinib Nivolumab to Ipilimumab Nivolumab in BRAF-V600 Mutant Melanoma with Brain Metastases

Led by SWOG Cancer Research Network · Updated on 2025-09-11

112

Participants Needed

331

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

CONDITIONS

Brief Title

A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have confirmed melanoma that has spread to the brain
Any primary melanoma type is allowed except uveal melanoma
Must have BRAF-V600 mutation confirmed by a certified laboratory
Brain MRI within 28 days before enrollment showing at least one measurable brain metastasis 0.5 cm or larger
Can have extracranial disease measured within 28-42 days before enrollment
May have leptomeningeal disease
Can be on corticosteroids for brain metastases at a dose no higher than 8 mg dexamethasone daily for at least 7 days before enrollment
Zubrod performance status of 2 or less
Must have complete history and physical exam within 28 days before enrollment
Must be able to swallow and keep pills
Hemoglobin 8.0 g/dL or higher within 28 days before enrollment
Absolute neutrophil count 1,500/mcL or higher within 28 days before enrollment
Platelets 75,000/mcL or higher within 28 days before enrollment
Total bilirubin at or below 1.5 times the upper limit of normal within 28 days before enrollment
AST and ALT at or below 2.5 times upper limit of normal (up to 5 times if liver metastases) within 28 days before enrollment
Creatinine at or below 2.0 times upper limit of normal within 28 days before enrollment
Cardiac function classified as New York Heart Association Class 2B or better if history of heart disease
Prior or concurrent cancers allowed if they do not affect study safety or results
People with HIV on effective treatment with undetectable viral load within 90 days prior to enrollment
People with treated and cured hepatitis C or undetectable viral load if currently treated
Must agree to participate in image banking and specimen collection
Must give informed consent according to guidelines
Institutional review board approval must be current

You will not qualify if you...

Prior systemic therapy for metastatic melanoma (prior neoadjuvant or adjuvant treatment allowed if disease relapsed)
Radiation therapy within 7 days before enrollment
Planning to start other systemic anti-tumor treatments during the study
Planning to use hormonal contraceptives
Serious active infection requiring treatment at enrollment
Active autoimmune disease treated with biologic agents within past 6 months
History of severe immune-related side effects from ipilimumab or nivolumab requiring long corticosteroid use
Prior adverse reactions to encorafenib or binimetinib requiring stopping the drugs
Pregnant or nursing women; men and women of reproductive potential must agree to use effective contraception excluding hormonal contraceptives

Research Team

Catrina Mireles

Dana Sparks

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