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NCT Number: NCT07449754

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

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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Key information

Conditions

Advanced or Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Belvarafenib

Drug

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

Other names: HM95573

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

Other names: Cotellic

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)

    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)

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)

    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)

  2. Duration of response (DOR)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)

    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.

  3. Progression-free survival (PFS)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)

    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

  4. Time to progression (TTP)

    Time frame: Throughout the study until disease progression (up to approximately 3 years)

    TTI will be measured from date of first treatment until date of rediographic progression as per RECIST v1.1 by Independent Central Review (ICR)

  5. Overall survival (OS)

    Time frame: Throughout the study until the date of death (up to approximately 3 years)

    OS will be measured from the first administration of the study drug to the date of death due to any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Young Su (Bobby) Noh

CONTACT

[email protected]

82-2-410-9277

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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