Belvarafenib plus cobimetinib for NRAS-mutant advanced or metastatic melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open‑label, single‑arm, multicenter trial of oral belvarafenib combined with cobimetinib given in 28‑day cycles to adults with NRAS‑mutant locally advanced or metastatic melanoma. The study will enroll patients who have measurable disease, adequate organ function, and an ECOG performance status of 0–2 and who have not received prior RAF/MEK/ERK inhibitors. Key outcomes include objective response rate, disease control rate, duration of response, time to progression, progression‑free survival, overall survival, and safety. Safety monitoring will include assessments for retinal, cardiac, bleeding, hematologic, hepatic, and renal adverse events.

Why it matters

Who can join: the full rules

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 ≤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's running

• Dong-A University Medical Center
  Busan, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting
• Asan Medical Center
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Not yet recruiting
• Chonnam National University Hwasun Hospital
  Hwasun, Jeollanam-do, South Korea Not yet recruiting

Study contacts

• Study coordinator: Young Su (Bobby) Noh
• Email: 63forever@hanmi.co.kr
• Phone: 82-2-410-9277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.