Advanced or Metastatic MelanomaPhase 2NCT07449754
Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
A Phase 2 study testing Belvarafenib and Cobimetinib in people with Advanced or Metastatic Melanoma, run by Hanmi Pharmaceutical Company Limited at 10 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced or Metastatic Melanoma
- What is being tested?
- Belvarafenib and Cobimetinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 12 Feb 2026to Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Dong-A University Medical Center
Busan, 49201
- Not yet recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
- Not yet recruiting
Chungnam National University Hospital
Daejeon, 35015
- Not yet recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Not yet recruiting
Korea University Guro Hospital
Seoul, 08308
About this study
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
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.
- Conditions
- Advanced or Metastatic Melanoma
- Being tested
- Belvarafenib, Cobimetinib
- Keywords
- NRAS-Mutant, Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelvarafenibDrug
Also called HM95573
Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle
CobimetinibCombination product
Also called Cotellic
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
| Study group | Role | What they receive |
|---|---|---|
| Belvarafenib + Cobimetinib | Experimental | Belvarafenib in combination with Cobimetinib Receives: Drug: Belvarafenib; Combination Product: Cobimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
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)
Measured: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Secondary outcomes (5)
Disease Control Rate (DCR)
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)
Measured: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Duration of response (DOR)
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.
Measured: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Progression-free survival (PFS)
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
Measured: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
Time to progression (TTP)
TTI will be measured from date of first treatment until date of rediographic progression as per RECIST v1.1 by Independent Central Review (ICR)
Measured: Throughout the study until disease progression (up to approximately 3 years)
Overall survival (OS)
OS will be measured from the first administration of the study drug to the date of death due to any cause
Measured: Throughout the study until the date of death (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start12 Feb 2026
- Primary completionSep 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449754
- Sponsor's protocol ID
- HM-RAFI-201
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07449754
- Acronym / sponsor ID
- HM-RAFI-201
- Conditions
- Advanced or Metastatic Melanoma
- Keywords
- NRAS-Mutant, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belvarafenib + Cobimetinib | Experimental | Drug: Belvarafenib, Combination Product: CobimetinibBelvarafenib in combination with Cobimetinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelvarafenibAlso: HM95573Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle | Drug | Belvarafenib + Cobimetinib |
| CobimetinibAlso: CotellicCobimetinib 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 | Combination product | Belvarafenib + Cobimetinib |
Primary outcome
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)
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belvarafenib and Cobimetinib in people with Advanced or Metastatic Melanoma, run by Hanmi Pharmaceutical Company Limited at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Su (Bobby) Noh (82-2-410-9277, 63forever@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.