Treatment for Advanced Melanoma
Study name: DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial
Description: Researchers at the WL Nugent Cancer Center are conducting a Phase III clinical trial for treating advanced melanoma that has spread beyond its local area and cannot be surgically removed in patients with a BRAFV600 mutation. This specific change in the BRAF gene may increase the growth and spread of cancer cells.
The purpose of this study is to determine what sequence of immunotherapy and BRAF inhibitor medications results in better patient outcomes. Immunotherapy medications use your body’s immune system to fight cancer, while BRAF inhibitor therapies may block tumor growth by targeting against BRAFV600.
- Treatment Sequence 1: First receive immunotherapy medications (ipilimumab and nivolumab). Then, if necessary, receive BRAF inhibitor medications (dabrafenib and trametinib).
- Treatment Sequence 2: First receive receive BRAF inhibitor medications (dabrafenib and trametinib). Then, if necessary, receive immunotherapy medications (ipilimumab and nivolumab).
Who can participate?
This study is open to men and women age 18 and over with:
- Stage 3 or 4 inoperable or metastatic melanoma
- BRAFV600 mutation detected in melanoma cells
- No other current malignancies
What to expect
- You will meet with your doctor to discuss what is involved in the study and the possible benefits and risks. If you and your doctor agree this clinical trial is right for you, you will be asked to sign a consent form.
- This is a randomized study, where you will be assigned by chance to one of the treatment sequences listed above.
- You will periodically complete questionnaires about your condition, side-effects from treatment, etc.
- Blood samples may be collected before, during, and after treatment for study analysis.
Please talk with your doctor about whether this clinical trial is right for you.