A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival (OS)
OS is defined for each subject as the time between randomization date and death. If a subject has not died, the subject will be censored at the time of last contact (last known alive date) OS will be assessed after 540 death events have occurred. Interim analysis after 360 deaths have occurred
Approximately 44 months after the first subject is randomized
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA184-169
NCT01515189
January 2012
December 2016
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
University of California Los Angeles | Los Angeles, California 90095-6951 |
Oncology Specialists, SC | Park Ridge, Illinois 60068 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
Baptist Cancer Institute | Jacksonville, Florida 32207 |
The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
New Mexico Cancer Care Alliance | Albuquerque, New Mexico 87106 |
Duke University Hospital | Durham, North Carolina 27710 |
Liberty Irb, Inc | DeLand, Florida 32720 |
St. Luke'S Cancer Center - Anderson Campus | Easton, Pennsylvania 18045 |