MelanomaNCT04666272
Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
An observational study of Melanoma, run by Novartis Pharmaceuticals at 8 sites in China.
Trial summary
This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Melanoma
- What is being tested?
- dabrafenib and trametinib
- How many people
- 78 participants
- Where
- 8 sitesChina
- Study dates
- 31 Dec 2020to 4 Feb 2028
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include Chinese patients with stage III BRAF V600 mutation positive melanoma treated with dabrafenib in combination with trametinib in a commercial setting.
Who may be able to join
- Patient(s) must meet all of the following criteria to be eligible for inclusion:
- ≥18 years old of age at the time of informed consent and of Chinese descent
- Signed written informed consent
- Going to receive commercial dabrafenib and trametinib according to approved label
- Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:
- for stage III cutaneous melanoma: as per American Joint Committee on Cancer (AJCC) 8th edition for melanoma
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- for stage III mucosal melanoma of the head and neck origin: as per AJCC 8th edition for mucosal melanoma of the head and neck
- for stage III mucosal melanoma of anal canal, rectum and genital track origin: as per Chinese guidelines on the diagnosis and treatment of melanoma 2019 edition
- Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Who cannot join
- Patient will be excluded from this study if he/she meets any of the following criteria:
- Known ocular melanoma
- Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
- Patient is not able to comply with the planned study procedures
- Taken an investigational drug within 28 days prior to enrolment
- History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Changsha, Hunan, 410013
Novartis Investigative Site
Fuzhou, Fujian, 350014
Novartis Investigative Site
Hangzhou, Zhejiang, 310022
Novartis Investigative Site
Kunming, Yunnan, 650106
Novartis Investigative Site
Nanjing, Jiangsu, 210008
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Zhengzhou, Henan, 410100
About this study
This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.
Read the detailed description
The study will consist of a treatment phase and follow-up phase. The treatment period is 12 months. Discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. Patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (EOT)
- Conditions
- Melanoma
- Being tested
- dabrafenib, trametinib
- Keywords
- BRAF V600 mutation-positive melanoma, cutaneous or mucosal melanoma, China, dabrafenib, trametinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenibDrug
There is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
trametinibDrug
There is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| dabrafenib in combination with trametinib as adjuvant treatment | Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used. Receives: Drug: dabrafenib; Drug: trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.
Measured: Up to 36 months
Secondary outcomes (2)
Overall survival (OS)
Overall survival (OS) defined as the time from start of treatment to death due to any cause
Measured: Up to 36 months
Safety of dabrafenib in combination with trametinib
Adverse events (AEs) and serious adverse events (SAEs) will be measured
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start31 Dec 2020
- Primary completion4 Feb 2028 (estimated)
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666272
- Sponsor's protocol ID
- CDRB436FCN01
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2020
- Last updated
- 19 Feb 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
- ClinicalTrials.gov ID
- NCT04666272
- Acronym / sponsor ID
- CDRB436FCN01
- Conditions
- Melanoma
- Keywords
- BRAF V600 mutation-positive melanoma, cutaneous or mucosal melanoma, China, dabrafenib, trametinib
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 4 Feb 2028 (estimated)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 14 Dec 2020 (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 prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.
Detailed description
The study will consist of a treatment phase and follow-up phase. The treatment period is 12 months. Discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. Patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (EOT)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dabrafenib in combination with trametinib as adjuvant treatment | – | Drug: dabrafenib, Drug: trametinibPatients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include Chinese patients with stage III BRAF V600 mutation positive melanoma treated with dabrafenib in combination with trametinib in a commercial setting.
Key inclusion criteria (11 listed)
- ≥18 years old of age at the time of informed consent and of Chinese descent
- Signed written informed consent
- Going to receive commercial dabrafenib and trametinib according to approved label
- Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:
- Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
Key exclusion criteria (6 listed)
- Known ocular melanoma
- Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
- Patient is not able to comply with the planned study procedures
- Taken an investigational drug within 28 days prior to enrolment
- History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.
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 |
|---|---|---|
| dabrafenibThere is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled. | Drug | dabrafenib in combination with trametinib as adjuvant treatment |
| trametinibThere is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled. | Drug | dabrafenib in combination with trametinib as adjuvant treatment |
Primary outcome
Relapse-free survival (RFS)
Time frame: Up to 36 months
Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.
2 secondary outcomes
Overall survival (OS)
Time frame: Up to 36 months
Safety of dabrafenib in combination with trametinib
Time frame: Up to 36 months
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 19 Feb 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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Novartis Pharmaceuticals at 8 sites in China.
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 11 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: Up to 36 months). 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 19 Feb 2026.