OncoMatch/Clinical Trials/NCT05026983
Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases
Is NCT05026983 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Binimetinib and Encorafenib for clinical stage iv cutaneous melanoma ajcc v8.
Treatment: Binimetinib · Encorafenib — This phase II trial studies the effects of binimetinib and encorafenib in treating patients with melanoma that has spread to the central nervous system (metastases). Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may help control melanoma that has spread to the brain.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: BRAF V600
Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistochemistry [IHC]) at any time prior to Screening or during Screening
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Pathologic Stage IV Cutaneous Melanoma AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BRAF inhibitor
Cohort A: Prior therapy with Food and Drug Administration (FDA)-approved BRAF inhibitors (+/- MEK inhibitors) is required
Cannot have received: BRAF inhibitor
Cohort B: BRAF V600 mutant melanoma patients who are treatment naive to BRAF/MEK inhibitors
Cannot have received: MEK inhibitor
Cohort B: BRAF V600 mutant melanoma patients who are treatment naive to BRAF/MEK inhibitors
Lab requirements
Blood counts
Absolute neutrophil count (ANC) 1.5 X 10^9/L; Hemoglobin 9.0 g/dL; Platelets 75 X 10^9/L; PT/INR and PTT <= 1.5 X ULN
Kidney function
Creatinine ≤ 1.5 X ULN OR calculated creatinine clearance ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min
Liver function
Total bilirubin <= 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%). AST and ALT ≤2.5 X ULN, in patients with liver metastases ≤5 X ULN. Albumin ≥2.5 g/dL.
Cardiac function
LVEF >= 50% as determined by MUGA or ECHO; Baseline QTcF interval < 480 msec
Absolute neutrophil count (ANC) 1.5 X 10^9/L Hemoglobin 9.0 g/dL Platelets 75 X 10^9/L PT/INR and PTT <= 1.5 X ULN Total bilirubin <= 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) AST and ALT ≤2.5 X ULN, in patients with liver metastases ≤5 X ULN Albumin ≥2.5 g/dL Creatinine ≤ 1.5 X ULN OR calculated creatinine clearance ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min LVEF >= 50% as determined by MUGA or ECHO; Baseline QTcF interval < 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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