Belvarafenib 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.

Trial Details

NCT ID
NCT07449754
Phase
PHASE2
Sponsor
Hanmi Pharmaceutical Company Limited
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Belvarafenib
  • Cobimetinib
Locations (sample)
  • Seongnam-si, Gyeonggi-do, South Korea|37.43861,127.13778
  • Hwasun, Jeollanam-do, South Korea|35.06125,126.98746
  • Busan, South Korea|35.10168,129.03004
  • Daegu, South Korea|35.87028,128.59111
  • Daejeon, South Korea|36.34913,127.38493

Key Eligibility Criteria

  • Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which st…
  • Have NRAS mutation.
  • Have at least one measurable lesion at baseline per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

For full eligibility, visit ClinicalTrials.gov.

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