Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
NCT ID: NCT01435369
Last Updated: 2016-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2011-11-30
2013-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CT-011 at dose level 1 (1.5 mg/kg).
CT-011
The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months.
CT-011 at dose level 2 (6 mg/kg).
CT-011
The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months.
Interventions
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CT-011
The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Medivation, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael B. Atkins, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Cancer Center
Locations
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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
Countries
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Other Identifiers
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2011-004501-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CT-2011-01
Identifier Type: -
Identifier Source: org_study_id
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