Study of Ipilimumab in the Immune System
|ClinicalTrials.gov Identifier: NCT01715077|
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma||Drug: Ipilimumab at 3 mg/kg dose||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Correlative Study of Melanoma Tumor-Infiltrating Lymphocytes (TILs) and Response to Ipilimumab|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
The recommended induction dose of ipilimumab is 3 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 3 mg/kg dose|
- TILs characteristics [ Time Frame: 2 years ]Tumor-infiltrating lymphocytes (TILs)will be observed before and after 3 mg/kg Ipilimumab is administered on patients with Stage III (unresectable) or Stage IV melanoma.
- Progression Free Survival (PFS) and Overall Survival (OS) [ Time Frame: 2 years on average ]To evaluate the Progression Free Survival (PFS) and Overall Survival (OS) in patients with previously untreated, metastatic melanoma.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715077
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Anthony Joshua, M.D||UHN-Princess Margaet Hospital|