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

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

NCT04511013

A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus 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

338 weeks

Total Duration

AI-Summary

What this Trial Is About

This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.

CONDITIONS

Official 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
Participants may have any primary melanoma type except uveal primary
Melanoma must have BRAF-V600 mutation confirmed by a certified laboratory
Brain MRI within 28 days before registration showing at least one measurable brain metastasis 0.5 cm not previously irradiated or progressed after radiation
Measurable or non-measurable extracranial disease assessed within 28 to 42 days before randomization
Participants may have leptomeningeal disease
Corticosteroid use up to 8 mg dexamethasone per day for brain metastases, stable for 7 days before randomization
Zubrod performance status 2
Complete history and physical exam within 28 days before randomization
Able to swallow and keep pills
Hemoglobin 8.0 g/dL within 28 days before randomization
Absolute neutrophil count 1,500/mcL within 28 days before randomization
Platelets 75,000/mcL within 28 days before randomization
Total bilirubin 1.5 times upper limit of normal within 28 days before randomization
AST and ALT 2.5 times upper limit of normal (or 5 times if liver metastases) within 28 days before randomization
Creatinine 2.0 times upper limit of normal within 28 days before randomization
Cardiac function classified as New York Heart Association class 2B or better if history of cardiac disease
Prior or concurrent malignancy allowed if not interfering with safety or efficacy
HIV-positive participants on effective therapy with undetectable viral load within 90 days
Treated and cured HCV infection; currently treated with undetectable viral load
Agree to image banking and specimen/blood collection
Must provide informed consent according to guidelines

You will not qualify if you...

Prior systemic therapy for metastatic disease is not allowed; prior neoadjuvant or adjuvant therapy allowed if relapse occurred
Radiation therapy within 7 days before randomization is not allowed
Planning additional systemic anti-tumor therapy during study treatment is not allowed
Use of hormonal contraceptives is not allowed
Serious active infections requiring systemic therapy at randomization are excluded
Active autoimmune disease treated with biologic disease-modifying agents in past 6 months is excluded
History of severe immune-related adverse events requiring prolonged corticosteroids from prior immunotherapy is excluded
Adverse events from encorafenib and/or binimetinib leading to discontinuation are excluded
Pregnant or nursing women are excluded; effective contraception required for those of reproductive potential
Patients must agree to avoid hormonal contraceptives during the study period

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Trial Site Locations

Total: 331 locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Actively Recruiting

Thomas Hospital

Fairhope, Alabama, United States, 36532

Actively Recruiting

Mobile Infirmary Medical Center

Mobile, Alabama, United States, 36607

Actively Recruiting

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Actively Recruiting

Alaska Breast Care and Surgery LLC