NCT07449754RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 12 Feb 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Diseases
- Melanoma
- NCT number
- NCT07449754
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 12 Feb 2026 to the primary completion date, 30 Sept 2029
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Have past history or ongoing cardiac function-related disorders.
Other
- Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dong-A University Medical Center Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Not yet recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Not yet recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Not yet recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Not yet recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.