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Home»Melanoma» An invitation to participate in a study examining the safety and efficacy of pembrolizumab, trametinib and dabrafenib in advanced melanoma
Clinical Trial
An invitation to participate in a study examining the safety and efficacy of pembrolizumab, trametinib and dabrafenib in advanced melanoma
The aim of this trial is to determine the effectiveness of the combination of pembrolizumab (Keytruda), dabrafenib (Tafinlar), and trametinib (Mekinist) as a treatment for patients with advanced melanoma. This trial will measure the safety and tolerability of the three therapies, as well as the progression-free survival time of the patients.
The details
The growth of some melanomas is due to a genetic mutation in the BRAF gene. This mutation leads to increased cancer cell growth. A treatment for patients with this mutation are BRAF inhibitors, which block the increased cell growth, including dabrafenib (Tafinlar) and trametinib (Mekinist).
Pembrolizumab (Keytruda) is an immunotherapy, a treatment that stimulates the immune system to fight cancer cells in the same way that it would fight a bacteria or virus. This trial will examine the effectiveness of the combination of pembrolizumab, dabrafenib, and trametinib in terms of increasing the time before disease progression, as well as the safety and tolerability of the treatment.
Who are they looking for?
This study will enroll 177 patients with advanced melanoma (spread to the lymph nodes or beyond to distant areas in the body). Patients must be BRAF-mutation positive, or, if negative, their disease must have progressed despite treatment. Patients must be able to swallow medication, and must have adequate gastrointestinal and other organ function.
Patients will be excluded if they are BRAF-mutation positive and have already undergone treatment, including other immunotherapies. Patients must not have had other forms of cancer, brain metastases (cancer that has spread to the brain), autoimmune diseases (in which the immune system attacks healthy tissue), cardiovascular disease, Hepatitis B or C, or HIV. Women must not be pregnant or breastfeeding, and both genders must agree to use contraception during the study.
How will it work
This trial has three parts. In the first two parts, patients will be randomly assigned to one of three groups. Group 1 will receive pembrolizumab on the 1st and 22nd days of a 6-week cycle, 150 mg of dabrafenib per day, and 2 mg of trametinib per day. Group 2 will receive only pembrolizumab and trametinib, and Group 3 will receive only pembrolizumab and dabrafenib.
In the third part of the trial, patients will be randomly assigned to two groups. Group 1 treatment remains the same as in the first two parts of the trial (pembrolizumab, dabrafenib and trametinib), while Group 2 will receive dabrafenib, trametinib, and a placebo, a substance that has no effect on the body used as a comparison.
The outcomes measured will include the safety and tolerability of the drug combination. In the third part of the trial, outcomes measured will also include the time from treatment to disease progression, and objective response rates (a measureable response such as tumor shrinkage).
