Ipilimumab + Temozolomide in Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT01119508|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : August 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Ipilimumab Drug: Temozolomide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Ipilimumab Plus Temozolomide in Patients With Metastatic Melanoma|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Ipilimumab + Temozolomide
Induction: Ipilimumab 10 mg/kg IV over 90 minutes Day 1 + Temozolomide 200 mg/m2 PO on Days 1 - 4, every 3 weeks for 4 courses over 3 months.
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.
Other Names: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.
Other Name: Temodar
- 6-Month Progression-Free Survival (PFS) Rate [ Time Frame: 6 Months ]Progression-free survival estimated using method of Kaplan-Meier. PFS determined from the start of study until disease progression or death, whichever is first. All patients who do not have a disease progression or death censored on their last evaluable tumor assessment date. PFS rate at 6 month provided with its 95% confidence interval estimated using bootstrap method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119508
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sapna P. Patel, MD||M.D. Anderson Cancer Center|