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New treatment option for Advanced or Metastatic Melanoma
Official title Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
ClinicalTrials.gov ID: NCT07449754
What this study is testing
What is Belvarafenib?
Belvarafenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced or metastatic melanoma.
Also referred to as HM95573.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which...
- 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
You likely can't join if
- 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).
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
- Hwasun, Jeollanam-do, South Korea
- Busan, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea; Hwasun, Jeollanam-do, South Korea; Busan, South Korea; Daegu, South Korea; Daejeon, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.