OncoMatch/Clinical Trials/NCT04511013
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Is NCT04511013 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for acral lentiginous melanoma.
Treatment: Binimetinib · Encorafenib · Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Tumor Agnostic
Biomarker criteria
Required: BRAF V600
Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; must have central nervous system metastases with at least one measurable brain metastasis >= 0.5 cm in size (per modified RECIST 1.1)
Performance status
ZUBROD 0–2
Prior therapy
Cannot have received: systemic therapy
Exception: Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting is permitted if patients had eventual disease relapse prior to randomization
Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting (e.g., BRAF/MEK inhibitor therapy, anti-PD-1 therapy or anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant/adjuvant therapy, they must have had eventual disease relapse prior to randomization
Cannot have received: radiation therapy
Participants must not have had prior radiation therapy within 7 days prior to randomization
Lab requirements
Blood counts
Hemoglobin >= 8.0 g/dL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 75,000/mcL
Kidney function
Creatinine <= 2.0 institutional ULN
Liver function
Total bilirubin <= 1.5 institutional ULN; AST and ALT <= 2.5 x institutional ULN (<= 5 x ULN with liver metastases)
Cardiac function
Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
Hemoglobin >= 8.0 g/dL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 75,000/mcL; Total bilirubin <= 1.5 institutional ULN; AST and ALT <= 2.5 x institutional ULN (<= 5 x ULN with liver metastases); Creatinine <= 2.0 institutional ULN; cardiac risk assessment using NYHA Functional Classification, must be class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Thomas Hospital · Fairhope, Alabama
- Mobile Infirmary Medical Center · Mobile, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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