334
Participants
Start Date
February 29, 2008
Primary Completion Date
October 31, 2009
Study Completion Date
December 31, 2011
Ipilimumab
Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
Paclitaxel
175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
Local Institution, New York
Local Institution, Torino
Local Institution, Marseille
Local Institution, Caen
Local Institution, Genova
Guthrie Clinical Research, Sayre
St. Mary Medical Center, Langhorne
Local Institution, Hamburg
The John R. Marsh Cancer Center, Hagerstown
Local Institution, Großhansdorf
Cmc-Northeast/ Northeast Oncology Associates, Concord
Santee Hematology/Oncology, Sumter
Georgia Cancer Specialists, Atlanta
M D Anderson Cancer Center- Orlando, Orlando
Local Institution, Rennes
Birmingham Hematology & Oncology Assoc. Llc, Birmingham
Kentucky Cancer Clinic, Hazard
Hematology Oncology Consultants, Inc, Columbus
Gabrail Cancer Center, Canton
Local Institution, Bochum
Local Institution, Kharkiv
Local Institution, Ternopil
Local Institution, Dnipropetrovsk
Local Institution, Cologne
Local Institution, Siena
Local Institution, Mainz
The Cancer Center, Minneapolis
Local Institution, Park Ridge
University Of Chicago Medical Center, Chicago
Local Institution, Lviv
Southwest Cancer Treatment And Research Center, Lubbock
Local Institution, München
Local Institution, Donetsk
Mayo Clinic, Scottsdale
Acrc/Arizona Clinical Research Center, Inc., Tucson
Local Institution, Uzhhorod
Nevada Cancer Institute, Las Vegas
Local Institution, Belfort
The Angeles Clinic & Research Institute, Inc, Los Angeles
Oncology Care Medical Associates, Montebello
Sharp Clinical Oncology Research, San Diego
Compassionate Cancer Care Medical Group, Riverside
Compassionate Cancer Care Medical Group, Inc., Fountain Valley
Compassionate Cancer Care Medical Group, Corona
Local Institution, Ebensfeld
Local Institution, Moscow
Local Institution, Moscow
Local Institution, Moscow
Local Institution, Ivanovo
Local Institution, Arkhangelsk
Local Institution, Saint Petersburg
Local Institution, Saint Petersburg
Local Institution, Saint Petersburg
Local Institution, Saint Petersburg
Local Institution, Saint Petersburg
Local Institution, Sochi
Local Institution, Pyatigorsk
Local Institution, Navrangpura, Ahmedabad
Local Institution, Chelyabinsk
Local Institution, Hyderabad
Local Institution, Manipal
Local Institution, Vellore
Local Institution, Trivandrum
Massachusetts General Hospital, Boston
Dartmouth-Hitchcock Medical Center, Lebanon
Local Institution, Coswig
Local Institution, Halle
Local Institution, Leipzig
Local Institution, Gdansk
Local Institution, Krakow
Local Institution, Olsztyn
Local Institution, Szczecin
Lead Sponsor
Bristol-Myers Squibb
INDUSTRY