DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial.

Protocol No
ECOG-EA6134
Principal Investigator
Amy Harker-Murray
Phase
III
Summary
The purpose of this research study is to compare the good and bad effects of the sequence of immunotherapy followed by BRAF inhibitor therapy if and when the disease becomes resistant, to the sequence of BRAF inhibitor therapy followed by immunotherapy if and when the disease becomes resistant. The BRAF inhibitor component will include the combination of two drugs dabrafenib and trametinib that each have been approved by the FDA for the treatment of this patient population and have also been approved for use in combination due to superior effects relative to the single agent treatments. In addition, the study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence. The combination of ipilimumab and nivolumab has been shown in recent studies to produce superior antitumor effects but also more side effects than ipilimumab alone. This combination has yet to receive FDA approval and is therefore still considered to be experimental. This research study will allow the investigators to determine which sequence of treatment has the best outcome for patients. To be better, one sequence should significantly improve the number of patients alive at 2 and 3 years from start of treatment relative to the alternative sequence. There will be about 300 people taking part in this study.
Description
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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