A Randomized, Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma

The purpose of this study is to compare any good and bad effects of receiving the drugs dabrafenib and trametinib continuously to receiving dabrafenib and trametinib with a break in treatment. Dabrafenib and trametinib are similar to vemurafenib and have been tested together and found to be safe and effective for patients with advanced melanoma. The combination has been approved by the FDA for the treatment of advanced melanoma. This study is testing whether receiving dabrafenib and trametinib with a break in treatment could extend the time before your cancer gets worse. It could also cause side effects. This study will allow the researchers to know whether a break in treatment is better, the same, or worse than continuous treatment of dabrafenib and trametinib. To be better, the break in treatment approach should extend the time before cancer gets worse by about 4 to 6 months compared to the continuous treatment approach. There will be about 280 people taking part in this study.

Are you Eligible? (Inclusion Criteria)

1. Patients must have histologically or cytologically confirmed Stage IV or unresectable Stage III BRAFV600E or BRAFV600K mutant melanoma.

2. Patients must not have received a prior BRAF or MEK inhibitor.

3. Patients must not have brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 7 days prior to registration.

4. Patients must not have received any major surgery, radiotherapy, or immunotherapy within 28 days prior to registration.

Specialty Area(s)

Trial Location

West 168th Street
New York, NY 10032
United States