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Also known as Binimetinib Oral Tablet
Binimetinib · 1 trial · 3 indications
Time from randomisation until IC-progressive disease (PD) as evaluated by centralized assessment using modified response evaluation criteria in solid tumours version 1.1 (RECIST v1.1), or death, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Encorafenib + binimetinib + pembrolizumab | EXPERIMENTAL | Encorafenib 450 mg oral route (PO) once daily (QD) + binimetinib 45 mg PO twice daily (BID) + pembrolizumab 200 mg intravenous (IV) every 3 weeks (Q3W). |
| SRS followed by encorafenib + binimetinib + pembrolizumab | EXPERIMENTAL | Upfront SRS of all lesions ≥5 mm in diameter (or ≥3 mm if other cerebral metastases \>5 mm); followed by encorafenib 450 mg PO QD + binimetinib 45 mg PO BID + pembrolizumab 200 mg IV Q3W. The treatment should be started more than 24 hours and less than 8 days (excluded) after the SRS |
| Name | Type | Description |
|---|---|---|
| Stereotaxic radiosurgery (SRS) | RADIATION | For patients randomised to arm B only: Upfront SRS of all lesions ≥5 mm in diameter (or ≥3 mm if other cerebral metastases \>5 mm). |
| Binimetinib Oral Tablet | DRUG | All patients: binimetinib 45 mg PO BID. |
| Encorafenib Oral Capsule | DRUG | All patients: encorafenib 450 mg PO QD |
| Pembrolizumab | DRUG | All patients: pembrolizumab 200 mg IV Q3W |
Inclusion Criteria: 1. Provided written informed consent prior to any trial specific procedures. 2. Aged ≥18 years old. 3. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 4. Histologically confirmed Stage IV M1d cutaneous melanoma or unknown primary melanoma that is metastat...
Binimetinib is an investigational small molecule being studied for the treatment of malignant melanoma, specifically in patients with BRAF V600 mutation and brain metastases. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
Binimetinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is being studied in combination with encorafenib and pembrolizumab, with or without stereotactic radiosurgery, for the treatment of BRAF V600 melanoma with brain metastasis.
Binimetinib is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the stock market. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with malignant melanoma.
Binimetinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness.
Binimetinib is being studied in a Phase 2 clinical trial with the identifier NCT04074096. This trial is evaluating the combination of binimetinib, encorafenib, and pembrolizumab, with or without stereotactic radiosurgery, in patients with BRAF V600 melanoma and brain metastases. The trial is active but not recruiting participants.
Yes, Binimetinib is also known as Binimetinib Oral Tablet. This alternative name refers to the oral formulation of the drug being studied in clinical trials for the treatment of malignant melanoma.