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OncoMatch/Clinical Trials/NCT06159478

Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

Is NCT06159478 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Binimetinib 15 MG for low-grade glioma.

Phase 2RecruitingNational Cancer Center, JapanNCT06159478Data as of May 2026

Treatment: Binimetinib 15 MGThis study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion/rearrangement.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Pancreatic Cancer

Biomarker criteria

Required: BRAF fusion

BRAF fusion or rearrangement is detected by reimbursed NGS-based cancer gene panel tests, cancer gene panel tests performed under advanced medical treatment, or clinical study (including liquid biopsy).

Required: BRAF rearrangement

BRAF fusion or rearrangement is detected by reimbursed NGS-based cancer gene panel tests, cancer gene panel tests performed under advanced medical treatment, or clinical study (including liquid biopsy).

Disease stage

Grade: 12 (who)

Prior therapy

Must have received: chemotherapy

Having progression after at least one regimen of chemotherapy excluding adjuvant therapy.

Cannot have received: MEK inhibitor (binimetinib)

Prior treatment with MEK inhibitors.

Lab requirements

Blood counts

Absolute neutrophil count >= 1,500/mm3; Platelet count >= 10.0 x 10^4/mm3; Hemoglobin >= 8.0 g/dL

Kidney function

Serum creatinine <= 1.5 mg/dL

Liver function

Total bilirubin <= 1.5 g/dL; AST <= 100 U/L; ALT <= 100 U/L

Cardiac function

Left ventricular ejection fraction >= 50% by echocardiography or MUGA within 28 days before registration; No cardiac effusion, pleural effusion, or ascites requiring treatment; No symptomatic congestive heart failure of NYHA class II-IV or arrhythmia (over grade 2) occurring in less than 6 months before registration; No myocardial infarction or unstable angina occurring in less than 6 months before registration; Corrected QT interval (QTcF) <= 480 ms in ECG performed within 14 days before enrollment.

Left ventricular ejection fraction >= 50% by echocardiography or MUGA (multigated acquisition scan) within 28 days before registration; No cardiac effusion, pleural effusion, or ascites requiring treatment; Laboratory tests within 14 days before registration and the values are within the following range. Patients should not receive administration of G-CSF and/or blood transfusion within 14 days before the blood collection (1) Absolute neutrophil count >= 1.500/mm3 (2) Platelet count >= 10.0 X 10(4))/mm3 (3) Hemoglobin >= 8.0 g/dL (4) Total bilirubin <= 1.5 g/dL (5) Aspartate aminotransferase (AST) <= 100 U/L (6) Alanine aminotransferase (ALT) <= 100 U/L (7) Serum creatinine <= 1.5 mg/dL

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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