Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

Status:	Completed
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/14/2017
Start Date:	November 2011
End Date:	August 2013

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.

Inclusion Criteria:

1. Participants must have a histologically or cytologically documented diagnosis of
metastatic melanoma.

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.

Exclusion Criteria:

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
investigational treatments.

5. Women of child bearing potential who are pregnant

Note: This is only a partial list of eligibility criteria.

We found this trial at

sites

Dana-Farber Cancer Institute

450 Brookline Ave
Boston, Massachusetts 2215

617-632-3000