Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
Trial Purpose and Description
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.
- 18 Years and older
1. Participants must have a histologically or cytologically documented diagnosis of
2. Participants age is 18 years or older.
3. Stage IV disease that is clearly progressive since last therapy
4. ECOG performance status of 0 or 1.
1. Patients with uveal melanoma.
2. Active autoimmune disease, symptoms or conditions except for vitiligo, type I
diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease
(eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no
therapy or manageable with NSAIDs.
3. Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
4. More than 3 prior lines of treatment for metastatic melanoma including approved and
5. Women of child bearing potential who are pregnant
Note: This is only a partial list of eligibility criteria.
- CureTech Ltd
- November 2011
- Last Updated:
- May 30, 2012
- Study HIC#:
Clinicaltrials.gov ID: NCT01435369