Ipilimumab + Temozolomide in Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01119508|
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Ipilimumab Drug: Temozolomide||Phase 2|
|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.
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 ]6-month progression free survival rate is defined as the number of participants without progression per RECIST 1.0 6 months after starting study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|