Study of Ipilimumab in the Immune System
Participants will be taking 10 mg/kg ipilimumab intravenously over a 90-minute period every 3 weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for functional characteristics.
Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma
Drug: Ipilimumab at 10 mg/kg dose
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Correlative Study of Melanoma Tumor-Infiltrating Lymphocytes (TILs) and Response to Ipilimumab|
- TILs characteristics [ Time Frame: 2 years ] [ Designated as safety issue: No ]Tumor-infiltrating lymphocytes (TILs)will be observed before and after 10mg/kg Ipilimumab is administered on patients with Stage III (unresectable) or Stage IV melanoma.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
The recommended induction dose of ipilimumab is 10 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of four doses, as guided by laboratory tests and patient assessment.
|Drug: Ipilimumab at 10 mg/kg dose|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715077
|Contact: Anthony Joshua, M.D||416-946-2520||Anthony.Joshua@uhn.ca|
|Princess Margaret Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Anthony Joshua, M.D|
|Principal Investigator:||Anthony Joshua, M.D||UHN-Princess Margaet Hospital|