Status:
COMPLETED
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
Lead Sponsor:
Medivation, Inc.
Conditions:
Melanoma
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 antibo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01435369
Start Date
November 1 2011
End Date
August 1 2013
Last Update
January 21 2016
Active Locations (18)
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1
Yale University School of Medicine, Section of Med Onc.
New Haven, Connecticut, United States, 06520
2
Moffitt Cancer Center Cutaneous Oncology Department
Tampa, Florida, United States, 33612
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
The University of Chicago
Chicago, Illinois, United States, 60637