Conditions: V600-mutated BRAF Unresectable Melanoma V600-mutated BRAF Metastatic Melanoma Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.

Detailed description:

Arms:
arm 1: Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts. arm 2: Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib arm 3: Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib arm 4: Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib

Interventions: intervention 1: PLX3397 intervention 2: vemurafenib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: