A Single Arm Open-Label Phase II study of Vemurafenib Followed by a Continuous Administration of Ipilimumab in Subjects with Previously Untreated V600 BRAF Mutated Advanced Melanoma
ID Number 12-1644Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to examine the safety of sequential (one after another) therapy of vemurafenib (Zelboraf®) and ipilimumab (Yervoy™), and find out whether this treatment schedule is safe for patients with regards to the main common side effects on the skin. This study is in subjects who have melanoma (a kind of skin cancer) and:
- their cancer has spread to other parts of the body or cannot be removed by surgery
(“advanced” stage), and
- there is a change (mutation) in the “BRAF” gene, and
- who have not been treated for this stage of the disease.
Ipilimumab is given at 10 mg/kg dose in this study. Ipilimumab, at a dose of 3 mg/kg, has been approved for treatment of metastatic melanoma by the US Food and Drug Administration (FDA), by the European Medicines Agency (EMA), and other regulatory authorities throughout the world. Ipilimumab at a dose of 10 mg/kg is not currently approved by health authorities such as the FDA.
Vemurafenib is a drug that is currently approved by the United States Food and Drug Administration (FDA) and by the European Medicines Agency (EMA). It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene.
In order to participate in the study, your disease (advanced melanoma) needs to be tested positive for the change (mutation) in the BRAF gene. This change may have led to the development of melanoma.
This study is an open label study. This means that both you and your study doctor will know what treatment you are receiving.
Recruiting Patients: Yes