Please check with your physician for additional protocols and/or information.
1. S1320: A Randomized Phase II Trial of Intermittent vs. Continuous Dosing of Dabrafenib & Trametinib in BRAF 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
If your BRAF mutation was determined by a test that is not FDA approved, there may be a higher probability that the test was false positive, which could result in risk with no potential for benefit from dabrafenib.
For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.