A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
For the extension phase:
Allocation: single arm study; Masking: open label; Intervention Model: Single Group
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall Survival
Patient Status is assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase)
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA184-024
NCT00324155
August 2006
August 2013
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Hematology Oncology, P.C. | Stamford, Connecticut 06902 |
Comprehensive Cancer Center | Glendale, California 91204 |
Oncology Specialists, SC | Park Ridge, Illinois 60068 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
University of Chicago | Chicago, Illinois 60637 |
Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Hematology Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
Sharp Clinical Oncology Research | San Diego, California 92123 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
Pacific Cancer Medical Center | Anaheim, California 92801 |
Hutchinson Clinic, PA | Hutchinson, Kansas 67502 |
Orlando Health, Inc. M.D. Anderson Cancer Center Orlando | Orlando, Florida 32806 |
St Joseph Oncology Inc | St Joseph, Missouri 64507 |
Wilshire Oncology Medical Group Inc | Laverne, California 91750 |
Mid-Illinois Hematology/Oncology Associates, Ltd. | Normal, Illinois 61761 |
St. Luke'S Hospital & Health Network | Bethlehem, Pennsylvania 18015 |
Lowcountry Hematology & Oncology, Pa | Mt. Pleasant, South Carolina 29464 |
Vanderbilt-Ingram Cancer Ctr | Nashville, Tennessee 37232 |
Cancer Specialists Of North Florida Beaches | Jacksonville, Florida 32256 |