RecruitingPhase 2NCT07449754

Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma


Sponsor

Hanmi Pharmaceutical Company Limited

Enrollment

45 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two targeted drugs — belvarafenib (a RAF inhibitor) and cobimetinib (a MEK inhibitor) — in people with advanced or metastatic melanoma (skin cancer that has spread) carrying a specific genetic mutation called NRAS. These drugs work by blocking two proteins in the same cancer growth pathway. **You may be eligible if:** - You are 19 years of age or older - You have been diagnosed with locally advanced or metastatic melanoma confirmed by biopsy - Your tumor carries an NRAS mutation - Your cancer has progressed after standard treatments or no standard treatment exists - You have at least one measurable tumor on imaging - Your general health is adequate (ECOG performance status ≤2) - Your kidney, liver, and blood counts are in acceptable range **You may NOT be eligible if:** - You have previously been treated with RAF, MEK, or ERK inhibitor drugs - You have a history of or current retinal eye disease (particularly conditions that could cause vision problems or retinal vein occlusion) - You have significant heart disease or heart rhythm problems - You had a serious bleeding event (Grade 3 or higher) within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBelvarafenib

Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle

COMBINATION_PRODUCTCobimetinib

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


Locations(10)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 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

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07449754