Phase 2 Study of Binimetinib for Patients with BRAF Fusion-Positive Low-Grade Glioma or Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer that have BRAF fusion or rearrangement. This Phase 2 trial is investigator-initiated and conducted across multiple centers, focusing on two separate groups one with low-grade glioma and the other with pancreatic cancer. The trial aims to understand how well binimetinib works in these specific cancer types by measuring response rates and other clinical outcomes. Participants receive binimetinib orally at a dose of 45 mg twice daily. The study includes two cohorts analyzed separately Cohort A for patients with low-grade glioma WHO grade 1 or 2 tumors aged 12 years or older, and Cohort B for patients with advanced or recurrent pancreatic cancer aged 18 years or older. Patients continue treatment and monitoring throughout the study until disease progression or other criteria are met. During the trial, participants undergo regular assessments including imaging scans to measure tumor response, laboratory tests, and evaluations of heart function. Researchers will track overall response rate centrally and by investigators, progression-free survival, overall survival, disease control, duration of response, and adverse events over a period of up to 4 years. Participants also provide informed consent and agree to contraception requirements if applicable. The study includes ongoing safety monitoring and detailed follow-up to evaluate the treatments impact.

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