Study of Ipilimumab in the Immune System

Sponsor: University Health Network, Toronto
Study ID: NCT01715077
Status: Completed

Conditions

Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Ipilimumab at 3 mg/kg dose — DRUG

Study Details

Participants will be taking 3 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.

Key Dates

Start date: Oct 31, 2012
Status verified: Aug 2018
Primary completion: Oct 31, 2017
Completion: Oct 31, 2017

Study Design

Enrollment: 4 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Ipilimumab
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.

Primary Outcome Measure

TILs characteristics [ Time Frame: 2 years ]