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Can a pill combo keep melanoma from coming back?

NCT ID NCT04666272

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

78 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

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

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

  • Novartis Investigative Site

    Fuzhou, Fujian, 350014, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 410100, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    Kunming, Yunnan, 650106, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022, China

  • Novartis Investigative Site

    Beijing, 100036, China

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