Can a pill combo keep melanoma from coming back?
NCT ID NCT04666272
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how well and how safely a combination of two cancer drugs, dabrafenib and trametinib, works when given after surgery to Chinese patients with stage III melanoma that has a specific gene change (BRAF V600). The goal is to see if the drugs help delay the cancer's return. About 78 patients will be followed over time, and researchers will track how long they stay cancer-free and any side effects they experience.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dabrafenib and trametinib (cancer drugs taken as pills)
- What this could lead to
- If successful, this could confirm that combining these drugs after surgery helps delay melanoma recurrence in Chinese patients.
- What could go wrong
- This is an observational study with no control group, so results may be less reliable. Side effects from the drugs can be serious, and the small size (78 patients) limits how broadly findings apply.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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78 people
The number who actually took part.
- Started
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Dec 2020
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patient(s) must meet all of the following criteria to be eligible for inclusion: 1. ≥18 years old of age at the time of informed consent and of Chinese descent 2. Signed written informed consent 3. Going to receive commercial dabrafenib and trametinib according to approved label 4. 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 * 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 5. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment 6. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains) 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Exclusion Criteria: Patient will be excluded from this study if he/she meets any of the following criteria: 1. Known ocular melanoma 2. Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature) 3. Patient is not able to comply with the planned study procedures 4. Taken an investigational drug within 28 days prior to enrolment 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Novartis Investigative Site
Fuzhou, Fujian, 350014, China
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Novartis Investigative Site
Zhengzhou, Henan, 410100, China
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Novartis Investigative Site
Wuhan, Hubei, 430022, China
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Novartis Investigative Site
Changsha, Hunan, 410013, China
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Novartis Investigative Site
Nanjing, Jiangsu, 210008, China
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Novartis Investigative Site
Kunming, Yunnan, 650106, China
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Novartis Investigative Site
Hangzhou, Zhejiang, 310022, China
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Novartis Investigative Site
Beijing, 100036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?