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

Completed · Phase 2

Conditions studied: Melanoma, Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT01435369

Run by

Medivation, Inc.

People needed

103

Starts

2011-11-01

Expected to finish

2013-08-01

Last updated by the study team

2016-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
• Participants age is 18 years or older.
• Stage IV disease that is clearly progressive since last therapy
• ECOG performance status of 0 or 1.

You may not qualify if…

• Patients with uveal melanoma.
• 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.
• Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
• More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
• Women of child bearing potential who are pregnant
• Note: This is only a partial list of eligibility criteria.

Where it is running

• Yale University School of Medicine, Section of Med Onc. — New Haven, Connecticut, United States
• Moffitt Cancer Center Cutaneous Oncology Department — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• The University of Chicago — Chicago, Illinois, United States
• Mass General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Ruttenberg Cancer Clinic - The Mount Sinai Hospital — New York, New York, United States
• Providence Cancer Center — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Univesity Medical Center — Dallas, Texas, United States
• University of Virginia Health System / Human Immune Therapy Center — Charlottesville, Virginia, United States
• Hadassah Medical Center — Jerusalem, Israel
• Chaim Sheba Medical Center — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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