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: - LY3022855 - Vemurafenib - Cobimetinib
Name: LY3022855
Name: Vemurafenib
Name: Cobimetinib
Description: Time from initiation of study therapy until documentation of disease progression by RECIST criteria
Measure: Progression Free Survival Time: 2 yearsDescription: Ability to give these three medications in combination without a dose limiting side effect. Assessment of side effects that do occur
Measure: Side effects from therapy Time: 2 yearsDescription: Rate of patients with a complete response or partial response as assessed by RECIST criteria
Measure: Overall Response Rate Time: 2 yearsDescription: At least a 30% decrease in the sum of the diameters of target lesions.
Measure: Partial Response Rate Time: 2 yearsDescription: Disease that is less than a 30% decrease or 20% increase in the sum of the diameters of the target lesions.
Measure: Stable Disease Time: 2 yearsDescription: At least a 20% increase in the sum of the diameters of target lesions.
Measure: Progressive Disease Time: 2 yearsDescription: Time from initiation of study therapy to death.
Measure: Overall Survival Time: 2 yearsDescription: Disappearance of all target lesions.
Measure: Complete response Time: 2 yearsAllocation: N/A
Single Group Assignment
There are 2 SNPs
LY3022855 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 The interventions involved in this study are: - LY3022855 - Vemurafenib - Cobimetinib Progression Free Survival. --- V600E ---
Disappearance of all target lesions.. 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 cannot have received prior BRAF or MEK inhibitor therapy. --- 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 ---
LY3022855 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 The interventions involved in this study are: - LY3022855 - Vemurafenib - Cobimetinib Progression Free Survival. --- V600E --- --- V600K ---
Disappearance of all target lesions.. 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 cannot have received prior BRAF or MEK inhibitor therapy. --- 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 ---