Conditions: Metastatic Melanoma
Keywords: Metastatic Melanoma Everolimus RAD001 Bevacizumab
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.

Detailed description:
All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression.

During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.

Fifty-five patients will be enrolled in this multi-centered study

Arms:
arm 1: All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.

Interventions: intervention 1: Bevacizumab intervention 2: Everolimus
Intervention descriptions: intervention 1: 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks. intervention 2: 10 mg by mouth daily

Protocol document: