Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Belvarafenib, Cobimetinib.
- Who it may be relevant to
- Registry conditions: Advanced or Metastatic Melanoma. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Belvarafenib
Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle - Combination product Cobimetinib
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
Primary outcome measures
- Objective response rate (ORR) [Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
Secondary outcome measures (5)
- Disease Control Rate (DCR) [Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
- Duration of response (DOR) [Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
- Progression-free survival (PFS) [Time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
- Time to progression (TTP) [Time frame: Throughout the study until disease progression (up to approximately 3 years)]
- Overall survival (OS) [Time frame: Throughout the study until the date of death (up to approximately 3 years)]
Eligibility criteria
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.
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 10 centers
- Seoul National University Bundang Hospital — Seongnam-si
- Chonnam National University Hwasun Hospital — Hwasun
- Dong-A University Medical Center — Busan
- Kyungpook National University Chilgok Hospital — Daegu
- Chungnam National University Hospital — Daejeon
- Seoul National University Hospital — Seoul
- Severance Hospital — Seoul
- Asan Medical Center — Seoul
- … and 2 more centers
Identifiers
NCT: NCT07449754 · HM-RAFI-201