Melanoma Clinical Trial
Official title:
Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
The purpose of this research study is to see if the study drug, CT-011, is safe to give and
if it helps people with melanoma that has spread to other areas of their body. CT-011 is a
monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by
infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab
instead of by the immune system which then recruit the immune system to help fight cancer
cells.
All final eligible subjects will receive an intravenous infusion of CT-011. This study will
test two dose levels of the study drug:
Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).
Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).
Each group will be given the study drug through an IV (a needle put into a vein in the arm)
on day 1. After day 1, the study drug will be given every other week. Patients may be given a
total of up to 27 study drug infusions for about 12 months while they are in the study.
Approximately 100 patients will participate in this study.
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