A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA184-041
NCT00527735
February 2008
December 2011
Name | Location |
---|---|
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Local Institution | Chicago, Illinois |
Local Institution | Bronx, New York |
Mayo Clinic | Scottsdale, Arizona |
ACRC/Arizona Clinical Research Center, Inc. | Tucson, Arizona 85712 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Compassionate Cancer Care medical Group, Inc. | Fountain Valley, California 92708 |
Santee Hematology/Oncology | Sumter, South Carolina 29150 |
Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
Sharp Clinical Oncology Research | San Diego, California 92123 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Oncology Care Medical Associates | Montebello, California 90640 |
Compassionate Cancer Care Medical Group | Corona, California 92882 |
St. Mary Medical Center | Langhorne, Pennsylvania 19047 |
Hematology Oncology Consultants, Inc | Columbus, Ohio 43235 |
Southwest Cancer Treatment and Research Center | Lubbock, Texas 79415 |
Birmingham Hematology & Oncology Assoc. Llc | Birmingham, Alabama 35235 |
The Angeles Clinic & Research Institute, Inc | Los Angeles, California 90025 |
The John R. Marsh Cancer Center | Hagerstown, Maryland 21740 |
The Cancer Center | Minneapolis, Minnesota 55455 |
Cmc-Northeast/ Northeast Oncology Associates | Concord, North Carolina 28025 |
Guthrie Clinical Research | Sayre, Pennsylvania 18840 |