This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation. The interventions involved in this study are: - MCS110 - Dabrafenib - Trametinib
Name: MCS110
Name: Dabrafenib
Name: Trametinib
Description: Any side effects or severe side effects that require the drug to be held or reduced
Measure: Dose Limiting Toxicity Time: 2 yearsDescription: The percentage of patients that have a reduction of their disease on imaging that meets RECIST criteria
Measure: Overall Response Rate Time: 2 yearsDescription: The percentage of patients who have a reduction of their disease on imaging to the point that it can no longer be measured.
Measure: Complete Response rate Time: 2 yearsDescription: The percentage of patients who have meet RECIST criteria for having a reduction in their disease on imaging but still have measurable disease.
Measure: Partial Response rate Time: 2 yearsDescription: The length of time between participants starting study treatment and having growth of their disease
Measure: Progression Free Survival Time: 2 yearsDescription: The amount of time between participants starting study therapy and death
Measure: Overall Survival Time: 2 yearsDescription: Any side effects or severe side effects associated with study therapy
Measure: Toxicity (Safety and Tolerability) Time: 2 yearsAllocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
MCS110 With BRAF/MEK Inhibition in Patients With Melanoma This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation. --- V600E ---
Inclusion Criteria: - For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. --- V600E ---
- For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and have had progression of disease on prior BRAF and MEK inhibitor therapy. --- V600E ---
MCS110 With BRAF/MEK Inhibition in Patients With Melanoma This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation. --- V600E --- --- V600K ---
Inclusion Criteria: - For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. --- V600E --- --- V600K ---
- For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and have had progression of disease on prior BRAF and MEK inhibitor therapy. --- V600E --- --- V600K ---