Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 211 people in the dabrafenib plus trametinib group and 212 people in the dabrafenib plus placebo group — 423 participants in total. The trial was measuring how long people with a type of skin cancer (melanoma) went without their disease getting worse (called "progression-free survival"), as well as how long people lived overall, how many people's tumours shrank or disappeared, and how long those responses lasted. Blood levels of the study medicines were also measured. The reported data shows that, for the main measure — the time until the disease got worse or the person died — the dabrafenib plus trametinib group had a reported median (the midpoint value for the group) of 10.2 months, compared with 8.8 months for the dabrafenib plus placebo group. For overall survival, the reported median was 25.8 months in the combination group and 18.7 months in the placebo group. Regarding tumour shrinkage or disappearance, 146 out of 211 participants in the combination group and 113 out of 212 in the placebo group were reported to have had a confirmed response. Among those who responded, the reported median time before the disease got worse again was 12.9 months in the combination group and 10.2 months in the placebo group. The reported data also shows blood level measurements for the study medicines at various time points throughout the trial; these figures confirmed that trametinib was detected in participants taking the active combination but not in those taking the placebo, as would be expected. The dabrafenib blood level figures were broadly similar across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34225229) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Melanoma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with skin melanoma (not eye or mouth/nose melanoma) that has either spread to nearby areas and cannot be removed by surgery (Stage IIIC), or has spread to other parts of the body (Stage IV)
- Your melanoma has tested positive for a specific gene change called BRAF V600E/K mutation, confirmed through a specific approved test at a central lab
- Your cancer can be seen and measured on a scan or imaging test
- You are able to carry out your normal daily activities without much difficulty (confirm with trial site)
- You are able to swallow and keep down oral medication (pills taken by mouth)
- If you are sexually active, you are willing to use an approved form of contraception during the study
- Your heart, liver, kidneys, and blood counts are working at an acceptable level
Who may not be able to join:
- You have previously been treated with a BRAF inhibitor or MEK inhibitor (specific types of targeted cancer drugs)
- You have already had systemic (whole-body) treatment for advanced or metastatic melanoma — though some earlier preventative treatments may be acceptable (confirm with trial site)
- You have had major surgery or certain cancer treatments within the 21 days before starting the trial
- You are currently taking certain medications that are not allowed in this trial (confirm with trial site for the full list)
- Your heart is not pumping blood as well as it should be
- You have blood pressure that is not under control
- You have a history of, or currently have, certain eye conditions affecting the blood vessels in your retina
- You have cancer that has spread to the brain, unless it was treated with surgery or a specific type of radiation at least 12 weeks ago and has been stable since then
- You are currently pregnant or breastfeeding
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression-Free Survival (PFS) as Assessed by the Investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.