Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Recruiting · NCT07449754 · Interventional (participants receive a specific treatment) · Lead sponsor: Hanmi Pharmaceutical Company Limited
View the official record on ClinicalTrials.gov →Interventions studied
BelvarafenibCobimetinib
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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Key
Exclusion criteria
- Have a history of prior treatment with RAF, MEK, or ERK inhibitor.
- Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.
- Have past history or ongoing cardiac function-related disorders.
- 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).
Where it is running
10 locations listed.
- Dong-A University Medical Center - Busan, South Korea
- Kyungpook National University Chilgok Hospital - Daegu, South Korea
- Chungnam National University Hospital - Daejeon, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Korea University Guro Hospital - Seoul, South Korea
- Seoul National University Bundang Hospital - Seongnam-si, Gyeonggi-do, South Korea
- Chonnam National University Hwasun Hospital - Hwasun, Jeollanam-do, South Korea