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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belvarafenib + Cobimetinib | Experimental | Belvarafenib in combination with Cobimetinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belvarafenib | Drug | Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years) |
| Duration of response (DOR) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Su (Bobby) Noh | Contact | 82-2-410-9277 | 63forever@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea | |
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| Cobimetinib | Combination Product | 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 |
|
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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. |
| 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 | 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) | 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 | Throughout the study until the date of death (up to approximately 3 years) |
| Chonnam National University Hwasun Hospital |
| Not yet recruiting |
| Hwasun |
| Jeollanam-do |
| 58128 |
| South Korea |
| Dong-A University Medical Center | Recruiting | Busan | 49201 | South Korea |
| Kyungpook National University Chilgok Hospital | Not yet recruiting | Daegu | 41404 | South Korea |
| Chungnam National University Hospital | Not yet recruiting | Daejeon | 35015 | South Korea |
| Seoul National University Hospital | Not yet recruiting | Seoul | 03080 | South Korea |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Not yet recruiting | Seoul | 08308 | South Korea |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C574276 | cobimetinib |
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