Melanoma EA6134

April 27, 2017

Sponsor: National Cancer Institute (NCI)

Number: EA6134

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) which studies how well initial treatment with Ipilimumab and Nivolumab followed by Dabrafenib and Trametinib works and compares it to initial treatment with Dabrafenib and Trametinib followed by Ipilimumab and Nivolumab in treating patients with stage III-IV  melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery. Stage IV is cancer which has spread from the site of the primary (original) tumor only to surrounding tissue, lymph nodes, or the development of secondary malignant growths at a distance from a primary site of cancer. Ipilimumab and Nivolumab may block tumor growth by targeting certain cells. Dabrafenib and Trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with Ipilimumab and Nivolumab followed by Dabrafenib and Trametinib is more effective than treatment with Dabrafenib and Trametinib followed by Ipilimumab and Nivolumab.

Who’s eligible:

• Women must not be pregnant or breast-feeding, and all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
• Patients must have measurable disease. All sites of disease must be evaluated within 4 weeks prior to randomization, and patients must have histological (tissue microscopically examined) or cytological (fluid cells microscopically examined) confirmation of melanoma that is metastatic or unresectable and clearly progressive.
• Patients must have BRAFV600E or BRAFV600K mutations, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Act (CLIA)-certified lab. If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test).
• This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.