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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
CT-011 at dose level 2 (6 mg/kg).	CT-011	-
CT-011 at dose level 1 (1.5 mg/kg).	CT-011	-

Primary Outcome Measures

Name	Time	Method
The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011	Approximately 28 months

Secondary Outcome Measures

Name	Time	Method
Safety of CT-011	Approximately 28 months	Safety will be assessed for incidence of Adverse Events
Progression Free Survival by Immune Related Response Criteria	Approximately 28 months
Overall Survival	Approximately 28 months

Locations (18): Moffitt Cancer Center Cutaneous Oncology Department
🇺🇸
Tampa, Florida, 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
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Baylor Univesity Medical Center
🇺🇸
Dallas, Texas, United States
University of Virginia Health System / Human Immune Therapy Center
🇺🇸
Charlottesville, Virginia, United States
Chaim Sheba Medical Center
🇮🇱
Tel Hashomer, Israel
Mass General Hospital
🇺🇸
Boston, Massachusetts, United States
Providence Cancer Center
🇺🇸
Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
The University of Chicago
🇺🇸
Chicago, Illinois, United States
Hadassah Medical Center
🇮🇱
Jerusalem, Israel
Yale University School of Medicine, Section of Med Onc.
🇺🇸
New Haven, Connecticut, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon,, New Hampshire, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States