Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations. The study plans to assess ORR, DCR, DOR, TTP, PFS, OS and safety of the participating subjects.

Treatment cycles for all subjects will be 28 days in duration and Belvarafenib and Cobimetinib will be administered orally in combination.

Key Inclusion Criteria:

• Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated.
• Have NRAS mutation.
• Have at least one measurable lesion at baseline per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Age of 19 years or older
• Adequate renal, hematologic and liver function.

Key Exclusion Criteria:

• Have a history of prior treatment with RAF, MEK, or ERK inhibitor.
• Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.
• Have past history or ongoing cardiac function-related disorders.
• Had hemorrhage or bleeding corresponding to CTCAE Grade ≥3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).