A Phase 2 interventional study of Belvarafenib and Cobimetinib in Advanced or Metastatic Melanoma, sponsored by Hanmi Pharmaceutical Company Limited. Recruiting at 10 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Hanmi Pharmaceutical Company Limited · Phase 2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 45 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Belvarafenib in combination with Cobimetinib
Drug: Belvarafenib · Combination Product: Cobimetinib
Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle
Also known as: HM95573
Cobimetinib will be taken on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle (three times weekly, TIW), followed by a drug holiday through Day 28
Also known as: Cotellic
Objective response rate (ORR)
ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Central Review (ICR)
Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Disease Control Rate (DCR)
DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 by Independent Central Review (ICR)
Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Duration of response (DOR)
DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 by Independent Central Review (ICR) or death from any cause, whichever occurs first.
Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Progression-free survival (PFS)
PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 by Independent Central Review (ICR) or until death from any cause, whichever occurs first
Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Time to progression (TTP)
TTI will be measured from date of first treatment until date of rediographic progression as per RECIST v1.1 by Independent Central Review (ICR)
Time frame: Throughout the study until disease progression (up to approximately 3 years)
Overall survival (OS)
OS will be measured from the first administration of the study drug to the date of death due to any cause
Time frame: Throughout the study until the date of death (up to approximately 3 years)
Plan to share: No
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Hanmi Pharmaceutical Company Limited