Actively Recruiting
Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-03-04
45
Participants Needed
10
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed locally advanced or metastatic melanoma with no adequate standard care, or where standard care 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 or less
- Be 19 years of age or older
- Have adequate kidney, blood, and liver function
You will not qualify if you...
- Prior treatment with RAF, MEK, or ERK inhibitors
- History or ongoing retinal problems considered a risk for retinopathy or retinal vein occlusion
- History or ongoing heart function disorders
- Had hemorrhage or bleeding of CTCAE Grade 3 or higher within 4 weeks before starting study treatment
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Not Yet Recruiting
2
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Not Yet Recruiting
3
Dong-A University Medical Center
Busan, South Korea, 49201
Actively Recruiting
4
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Not Yet Recruiting
5
Chungnam National University Hospital
Daejeon, South Korea, 35015
Not Yet Recruiting
6
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
7
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
8
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
9
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
10
Korea University Guro Hospital
Seoul, South Korea, 08308
Not Yet Recruiting
Research Team
Y
Young Su (Bobby) Noh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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