550
Participants
Start Date
June 13, 2017
Primary Completion Date
February 10, 2020
Study Completion Date
December 4, 2023
ONO-4538
360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Carboplatin
Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Paclitaxel
Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Bevacizumab
Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Placebo
Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Aichi Clinical Site2, Nagoya
Aichi Clinical Site3, Nagoya
Aichi Clinical Site4, Nagoya
Aichi Clinical Site, Nagoya
Aichi Clinical Site, Toyoake
Aomori Clinical Site2, Hirosaki
Aomori Clinical Site, Hirosaki
Chiba Clinical Site, Yachiyo
Ehime Clinical Site, Matsuyama
Fukuoka Clinical Site, Iizuka
Fukuoka Clinical Site, Kitakyushu
Fukuoka Clinical Site, Koga
Fukuoka Clinical Site, Kurume
Fukushima Clinical Site, Kōriyama
Gunma Clinical Site, Ōta
Gunma Clinical Site, Shibukawa
Hokkaido Clinical Site, Asahikawa
Hokkaido Clinical Site2, Sapporo
Hokkaido Clinical Site, Sapporo
Hyogo Clinical Site, Akashi
Hyogo Clinical Site, Amagasaki
Hyogo Clinical Site, Himeji
Hyogo Clinical Site, Itami
Hyogo Clinical Site, Kobe
Hyogo Clinical Site, Nishinomiya
Hyogo Clinical Site, Takarazuka
Ibaraki Clinical Site, Higashiibaraki
Ibaraki Clinical Site, Kasama
Ibaraki Clinical Site, Tsuchiura
Ishikawa Clinical Site2, Kanazawa
Ishikawa Clinical Site3, Kanazawa
Ishikawa Clinical Site, Kanazawa
Iwate Clinical Site, Morioka
Kanagawa Clinical Site, Isehara
Kanagawa Clinical Site2, Kawasaki
Kanagawa Clinical Site, Kawasaki
Kanagawa Clinical Site, Sagamihara
Kanagawa Clinical Site2, Yokohama
Kanagawa Clinical Site3, Yokohama
Kanagawa Clinical Site, Yokohama
Kumamoto Clinical Site, Kōshi
Kyoto Clinical Site, Jōyō
Mie Clinical Site, Tsu
Miyagi Clinical Site, Natori-shi
Miyagi Clinical Site, Sendai
Nagano Clinical Site, Matsumoto
Nagasaki Clinical Site, Ōmura
Nara Clinical Site, Ikoma
Niigata Clinical Site, Nagaoka
Oita Clinical Site, Beppu
Oita Clinical Site, Yufu
Osaka Clinical Site, Habikino
Osaka Clinical Site, Hirakata
Osaka Clinical Site, Kishiwada
Osaka Clinical Site, Sakai
Osaka Clinical Site, Sayama
Osaka Clinical Site, Toyonaka
Osaka Clinical Site2, Osaka
Saga Clinical Site, Ureshino
Saitama Clinical Site, Hidaka
Saitama Clinical Site, Kitaadachi-gun
Shimane Clinical Site, Izumo
Shizuoka Clinical Site, Hamamatsu
Shizuoka Clinical Site, Sunto-gun
Tokyo Clinical Site2, Bunkyo-ku
Tokyo Clinical Site, Bunkyo-ku
Tokyo Clinical Site2, Bunkyō-Ku
Tokyo Clinical Site2, Chuo-ku
Tokyo Clinical Site, Chuo-ku
Tokyo Clinical Site, Fuchū
Tokyo Clinical Site, Itabashi-ku
Tokyo Clinical Site, Kiyose
Tokyo Clinical Site, Koto-ku
Tokyo Clinical Site, Meguro City
Tokyo Clinical Site, Minato-ku
Tokyo Clinical Site, Mitaka-shi
Tokyo Clinical Site, Shibuya City
Tokyo Clinical Site2, Shinjuku-Ku
Tokyo Clinical Site3, Shinjuku-Ku
Tokyo Clinical Site, Shinjuku-ku
Tokyo Clinical Site, Tachikawa
Tottori Clinical Site, Yonago
Yamaguchi Clinical Site, Iwakuni
Chiba Clinical Site2, Chiba
Chiba Clinical Site, Chiba
Fukui Clinical Site, Fukui
Fukuoka Clinical Site2, Fukuoka
Fukuoka Clinical Site3, Fukuoka
Fukuoka Clinical Site4, Fukuoka
Fukuoka Clinical Site, Fukuoka
Gifu Clinical Site2, Gifu
Gifu Clinical Site, Gifu
Hiroshima Clinical Site2, Hiroshima
Hiroshima Clinical Site, Hiroshima
Kochi Clinical Site, Kochi
Kumamoto Clinical Site, Kumamoto
Kyoto Clinical Site, Kyoto
Nagasaki Clinical Site, Nagasaki
Niigata Clinical Site2, Niigata
Niigata Clinical Site, Niigata
Okayama Clinical Site2, Okayama
Okayama Clinical Site, Okayama
Osaka Clinical Site3, Osaka
Osaka Clinical Site, Osaka
Oita Clinical Site, Ōita
Tokushima Clinical Site, Tokushima
Toyama Clinical Site2, Toyama
Toyama Clinical Site, Toyama
Wakayama Clinical Site, Wakayama
Yamaguchi Clinical Site, Yamaguchi
Gangwon-Do Clinical Site, Wŏnju
Gyeonggi-do Clinical Site2, Seongnam-si
Gyeonggi-do Clinical Site, Seongnam-si
Gyeonggi-do Clinical Site, Suwon
Gyeongsangnam-do Clinical Site, Jinju
Chungcheongbuk-do Clinical Site, Cheongju-si
Busan Clinical Site, Busan
Daegu Clinical Site, Daegu
Incheon Clinical Site, Incheon
Seoul Clinical Site2, Seoul
Seoul Clinical Site3, Seoul
Seoul Clinical Site4, Seoul
Seoul Clinical Site5, Seoul
Seoul Clinical Site6, Seoul
Seoul Clinical Site, Seoul
Changhua Clinical Site, Changhua
Chiayi Clinical Site, Chiayi City
Kaohsiung Clinical Site2, Kaohsiung City
Kaohsiung Clinical Site3, Kaohsiung City
Kaohsiung Clinical Site, Kaohsiung City
Taichung Clinical Site, Taichung
Tainan Clinical Site, Tainan City
Taipei Clinical Site2, Taipei
Taipei Clinical Site, Taipei
Taoyuan Clinical Site, Taoyuan District
Lead Sponsor
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY