Approval Probability
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Belvarafenib · 1 trial · 1 indication
Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
| Arm | Type | Description |
|---|---|---|
| Belvarafenib Monotherapy | EXPERIMENTAL | Twice daily (BID), continuous dosing. |
| Belvarafenib Plus Cobimetinib | EXPERIMENTAL | Recommended dose (RD) and schedule of belvarafenib and cobimetinib selected based on the safety data, tolerability, pharmacokinetics, and anti-tumor activity tested in dose-finding phase followed by an expansion phase. |
| Belvarafenib Plus Cobimetinib Plus Nivolumab | EXPERIMENTAL | Recommended dose (RD) and schedule of belvarafenib and cobimetinib plus nivolumab IV infusion every 4 weeks (Q4W) in a run-in phase followed by an expansion phase |
| Name | Type | Description |
|---|---|---|
| Belvarafenib | DRUG | Twice daily (BID), continuous dosing |
| Cobimetinib | DRUG | Once daily (QD) or three times weekly (TIW) for 21 days, 7 days off |
| Nivolumab | DRUG | Once every 4 weeks (Q4W) |
Inclusion Criteria: * ECOG Performance Status of 0 or 1 * Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received ...
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Belvarafenib is an investigational small molecule being studied for the treatment of NRAS-mutant advanced melanoma. It is being evaluated as a single agent and in combination with cobimetinib or cobimetinib plus nivolumab in patients with this specific biomarker-selected population. It is not yet approved for any indication.
Belvarafenib targets RAF1, BRAF, and ARAF kinases. It is a small molecule inhibitor designed to inhibit these RAF family kinases, which are components of the MAPK signaling pathway often dysregulated in NRAS-mutant melanoma.
Belvarafenib is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical trial evaluating the drug in NRAS-mutant advanced melanoma.
Belvarafenib is in Phase 1 clinical development. The ongoing trial is a Phase 1 study evaluating its safety and activity as a single agent and in combinations. It is investigational and has not been approved by the FDA or any regulatory agency.
Belvarafenib is being studied in one active clinical trial, NCT04835805, titled "A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma." The trial is active but not recruiting, with an estimated enrollment of 65 patients across the United States, Australia, Canada, Germany, and South Korea.