Belvarafenib with cobimetinib for advanced melanoma with an NRAS gene change
Tests belvarafenib plus cobimetinib in adults with advanced NRAS-mutant melanoma.
Plain-language title generated from the registry record
Registry title: Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Key facts
- Where
- Busan, Daegu, Daejeon, Hwasun, Seongnam-si, and Seoul, South KoreaSee the 10 sites
- Phase
- Phase 2
Where in South Korea
- Dong-A University Medical CenterBusan, South KoreaTaking people
- Kyungpook National University Chilgok HospitalDaegu, South KoreaNot yet recruiting
- Chungnam National University HospitalDaejeon, South KoreaNot yet recruiting
- Chonnam National University Hwasun HospitalHwasun, South KoreaNot yet recruiting
- Seoul National University Bundang HospitalSeongnam-si, South KoreaNot yet recruiting
- Asan Medical CenterSeoul, South KoreaTaking people
- Korea University Guro HospitalSeoul, South KoreaNot yet recruiting
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaNot yet recruiting
- Severance hospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hanmi Pharmaceutical Company Limited
- Trial code
- NCT07449754
- Record updated
- 4 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Have a history of prior treatment with RAF, MEK, or ERK inhibitor; 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); Have past history or ongoing cardiac function-related disorders; Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.