Ipilimumab + Temozolomide in Metastatic Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Metastatic Melanoma
Interventions
DRUG

Ipilimumab

Induction Phase: 10 mg/kg by vein (IV) over approximately 90 minutes on Day 1 only repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose repeated every 12 weeks.

DRUG

Temozolomide

Induction Phase, 200 mg/m\^2 by mouth (PO) on Days 1 to 4, repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose delivered on Days 1 to 5, repeated every 4 weeks.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER