NCT07449754

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced or Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Belvarafenib	Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle
COMBINATION_PRODUCT	Cobimetinib	Cobimetinib will be taken on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle (three times weekly, TIW), followed by a drug holiday through Day 28

Timeline

• Start date: 2026-02-12
• Primary completion: 2029-09-01
• Completion: 2030-03-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

10 sites across 1 country: South Korea