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โ† Trials
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Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

RecruitingPhase 2Ages 19 Years - anyAllHanmi Pharmaceutical Company Limited
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key 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 โ‰ค2 * 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 โ‰ฅ3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).
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What it tests

  • Belvarafenib
  • Cobimetinib
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Where

10 sites
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
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

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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