This trial aims to investigate the effects of the anti-cancer drugs dabrafenib (Taflinlar) and trametinib (Mekinist) on fever related side effects when treating patients with advanced melanoma that has been surgically removed. The main outcome that will be measured is the rate of fever and raised body temperature.
The details
High body temperature (fever) is a common side effect of cancer therapy. It can be dangerous if not well managed. Fever is a very common side effect of treatment with dabrafenib and trametinib.
This trial is evaluating the effects of the anti-cancer drugs dabrafenib and trametinib on fever related side effects when treating patients with advanced melanoma that has been surgically removed. The main outcome that will be measured is the rate of fever and raised body temperature, as well as survival rates.
Who are they looking for?
The study is recruiting 600 patients with surgically removed stage III melanoma. To be included in this trial, patients must have BRAF positive (an abnormal gene) melanoma, either V600E or V600K. The main tumor must be able to be identified. Patients may also have stage I or II melanoma with cancer spread to the lymph nodes that can be removed.
Patients will be excluded from the trial if they have received any treatment other than surgical removal of the tumor. Patients with cancer spread to other organs or another cancer will be excluded. Any heart problems or other concurrent illnesses will result in the patient being excluded from the trial.
How will it work
This trial will consist of one group. Subjects will receive dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months. The patients will be assessed during treatment to see how often fever is a side effect of this treatment. They will be followed up for up to 24 months.
