Phase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to test the safety and side effects of the study drug navitoclax in combination with dabrafenib and trametinib at different doses.
Melanoma with a mutation, a change in a cancer gene called BRAF that helps cancer grow
Who Can Participate in the Study?
Adults with BRAF-mutant (V600E/K) melanoma that is metastatic (has spread) or is unresectable (cannot be removed using surgery) and for which standard curative measures do not exist or are no longer effective.
What is Involved?
This study is divided into two parts.
In the first part of this study, you will receive navitoclax for one week by itself before dabrafenib and trametinib are started.
The second part of this study has two study groups.
If you are enrolled in the second part of this study, a computer will randomly (like flipping a coin) put you in a study group. This is done because no one knows if one study group is better, the same, or worse than the other group. Once you are put in one group, you cannot switch to the other group.
Group 1 will get the usual drug combination used for this type of cancer dabrafenib plus trametinib plus a study drug called navitoclax.
Group 2 will get only the usual drug combination used for this type of cancer consisting of dabrafenib plus trametinib.