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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGChonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
NOT_YET_RECRUITINGDong-A University Medical Center
Busan, South Korea
RECRUITINGKyungpook National University Chilgok Hospital
Daegu, South Korea
NOT_YET_RECRUITINGChungnam National University Hospital
Daejeon, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGKorea University Guro Hospital
Seoul, South Korea
NOT_YET_RECRUITINGObjective 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)
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