Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
680 participants
INTERVENTIONAL
2016-03-31
2022-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ONO-4538 + SOX Therapy Cohort (Part 1)
ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (BSA) solution intravenously for 2 hours once-daily, followed by 20 days off.
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
ONO-4538
Oxaliplatin
Tegafur- Gimeracil-Oteracil potassium
ONO-4538 + CapeOX Therapy Cohort (Part 1)
ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Capecitabine 1200 - 2100 mg bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
ONO-4538
Oxaliplatin
Capecitabine
ONO-4538 + chemotherapy group (Part 2)
With regard to the ONO-4538 + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject.
ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off.
Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
ONO-4538
Oxaliplatin
Tegafur- Gimeracil-Oteracil potassium
Capecitabine
Placebo + Chemotherapy group (Part 2)
With regard to the placebo + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject.
Placebo solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off.
Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Oxaliplatin
Tegafur- Gimeracil-Oteracil potassium
Capecitabine
Placebo
Interventions
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ONO-4538
Oxaliplatin
Tegafur- Gimeracil-Oteracil potassium
Capecitabine
Placebo
Eligibility Criteria
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Inclusion Criteria
* Have measurable lesions as defined in RECIST Guideline Version 1.1
* ECOG PS score 0 or 1
* Have a life expectancy of at least 3 months
Exclusion Criteria
* Have a current or past history of severe hypersensitivity to any other antibody products
* Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
* Patients with active, known or suspected autoimmune disease
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Mitsunobu Tanimoto
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aichi Clinical Site
Nagoya, Aichi-ken, Japan
Aomori Clinical Site
Hirosaki, Aomori, Japan
Aomori Clinical Site
Misawa, Aomori, Japan
Chiba Clinical Site
Funabashi, Chiba, Japan
Chiba Clinical Site
Kamogawa, Chiba, Japan
Chiba Clinical Site
Kashiwa, Chiba, Japan
Ehime Clinical Site1
Matsuyama, Ehime, Japan
Ehime Clinical Site2
Matsuyama, Ehime, Japan
Fukuoka Clinical Site
Iizuka, Fukuoka, Japan
Fukuoka Clinical Site1
Kitakyushu, Fukuoka, Japan
Fukuoka Clinical Site2
Kitakyushu, Fukuoka, Japan
Fukuoka Clinical Site
Kurume, Fukuoka, Japan
Gifu Clinical Site
Gifu, Gifu, Japan
Gifu Clinical Site
Ōgaki, Gifu, Japan
Gumma Clinical Site
Maebashi, Gunma, Japan
Gunma Clinical Site
Ōta, Gunma, Japan
Gumma Clinical Site
Takasaki, Gunma, Japan
Hiroshima Clinical Site
Kure, Hiroshima, Japan
Hokkaido Clinical Site
Hakodate, Hokkaido, Japan
Hokkaido Clinical Site1
Sapporo, Hokkaido, Japan
Hokkaido Clinical Site2
Sapporo, Hokkaido, Japan
Hokkaido Clinical Site3
Sapporo, Hokkaido, Japan
Hokkaido Clinical Site4
Sapporo, Hokkaido, Japan
Hyogo Clinical Site
Akashi, Hyōgo, Japan
Hyogo Clinical Site
Amagasaki, Hyōgo, Japan
Hyogo Clinical Site
Kobe, Hyōgo, Japan
Hyogo Clinical Site
Nishinomiya, Hyōgo, Japan
Ibaraki Clinical Site
Higashiibaraki-gun, Ibaraki, Japan
Ibaraki Clinical Site
Tsuchiura-shi, Ibaraki, Japan
Ishikawa Clinical Site1
Kanazawa, Ishikawa-ken, Japan
Ishikawa Clinical Site2
Kanazawa, Ishikawa-ken, Japan
Iwate Clinical Site
Morioka, Iwate, Japan
Kagawa Clinical Site
Kita-gun, Kagawa-ken, Japan
Kanagawa Clinical Site
Isehara, Kanagawa, Japan
Kanagawa Clinical Site
Kamakura, Kanagawa, Japan
Kanagawa Clinical Site
Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site1
Yokohama, Kanagawa, Japan
Kanagawa Clinical Site2
Yokohama, Kanagawa, Japan
Kanagawa Clinical Site3
Yokohama, Kanagawa, Japan
Miyagi Clinical Site
Natori-shi, Miyagi, Japan
Miyagi Clinical Site
Ōsaki, Miyagi, Japan
Miyagi Clinical Site
Sendai, Miyagi, Japan
Nagano Clinical Site
Saku, Nagano, Japan
Nara Clinical Site
Ikoma, Nara, Japan
Nara Clinical Site
Kashihara-shi, Nara, Japan
Okayama Clinical Site
Kurashiki, Okayama-ken, Japan
Osaka Clinical Site
Izumi, Osaka, Japan
Osaka Clinical Site
Sakai, Osaka, Japan
Osaka Clinical Site
Sayama, Osaka, Japan
Osaka Clinical Site
Suita, Osaka, Japan
Osaka Clinical Site
Takatsuki, Osaka, Japan
Osaka Clinical Site
Toyonaka, Osaka, Japan
Saitama Clinical Site
Hidaka, Saitama, Japan
Saitama Clinical Site
Kitaadachi-gun, Saitama, Japan
Shizuoka Clinical Site
Hamamatsu, Shizuoka, Japan
Tochigi Clinical Site
Shimotsuke, Tochigi, Japan
Tochigi Clinical Site
Utsunomiya, Tochigi, Japan
Tokyo Clinical Site
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site
Fuchū, Tokyo, Japan
Tokyo Clinical Site
Koto-ku, Tokyo, Japan
Tokyo Clinical Site
Minato-ku, Tokyo, Japan
Tokyo Clinical Site
Shinagawa-ku, Tokyo, Japan
Tokyo Clinical Site1
Shinjuku-ku, Tokyo, Japan
Tokyo Clinical Site2
Shinjuku-ku, Tokyo, Japan
Tokyo Clinical Site
Tachikawa, Tokyo, Japan
Tottori Clinical Site
Yonago, Tottori, Japan
Yamagata Clinical Site
Sakata, Yamagata, Japan
Akita Clinical Site
Akita, , Japan
Chiba Clinical Site1
Chiba, , Japan
Chiba Clinical Site2
Chiba, , Japan
Fukui Clinical Site
Fukui, , Japan
Fukuoka Clinical Site1
Fukuoka, , Japan
Fukuoka Clinical Site2
Fukuoka, , Japan
Fukuoka Clinical Site3
Fukuoka, , Japan
Fukuoka Clinical Site4
Fukuoka, , Japan
Fukushima Clinical Site
Fukushima, , Japan
Hiroshima Clinical Site1
Hiroshima, , Japan
Hiroshima Clinical Site2
Hiroshima, , Japan
Hiroshima Clinical Site3
Hiroshima, , Japan
Kumamoto Clinical Site1
Kumamoto, , Japan
Kumamoto Clinical Site2
Kumamoto, , Japan
Kumamoto Clinical Site3
Kumamoto, , Japan
Kyoto Clinical Site1
Kyoto, , Japan
Kyoto Clinical Site2
Kyoto, , Japan
Kyoto Clinical Site3
Kyoto, , Japan
Niigata Clinical Site
Niigata, , Japan
Okayama Clinical Site
Okayama, , Japan
Osaka Clinical Site1
Osaka, , Japan
Osaka Clinical Site2
Osaka, , Japan
Osaka Clinical Site3
Osaka, , Japan
Osaka Clinical Site4
Osaka, , Japan
Shizuoka Clinical Site
Shizuoka, , Japan
Tokushima Clinical Site
Tokushima, , Japan
Toyama Clinical Site
Toyama, , Japan
Wakayama Clinical Site
Wakayama, , Japan
Yamagata Clinical Site
Yamagata, , Japan
Gyeongnam Clinical Site
Gyeongnam, Gyeongsangnam-do, South Korea
Busan Clinical Site
Busan, , South Korea
Daegu Clinical Site 1
Daegu, , South Korea
Daegu Clinical Site 2
Daegu, , South Korea
Daejeon Clinical Site
Daejeon, , South Korea
Gyeonggi-Do Clinical Site1
Gyeonggi-do, , South Korea
Gyeonggi-Do Clinical Site2
Gyeonggi-do, , South Korea
Gyeonggi-Do Clinical Site3
Gyeonggi-do, , South Korea
Gyeonggi-Do Clinical Site4
Gyeonggi-do, , South Korea
Gyeonggi-Do Clinical Site5
Gyeonggi-do, , South Korea
Incheon Clinical Site
Incheon, , South Korea
Jeollabuk-Do Clinical Site
Jeollabuk-Do, , South Korea
Jeollanam-do Clinical Site
Jeollanam-do, , South Korea
Seoul Clinical Site 1
Seoul, , South Korea
Seoul Clinical Site 2
Seoul, , South Korea
Seoul Clinical Site 3
Seoul, , South Korea
Seoul Clinical Site 4
Seoul, , South Korea
Seoul Clinical Site 5
Seoul, , South Korea
Seoul Clinical Site 6
Seoul, , South Korea
Seoul Clinical Site7
Seoul, , South Korea
Seoul Clinical Site8
Seoul, , South Korea
Seoul Clinical Site9
Seoul, , South Korea
Ulsan Clinical Site
Ulsan, , South Korea
Kaohsiung Clinical Site1
Kaohsiung City, , Taiwan
Kaohsiung Clinical Site2
Kaohsiung City, , Taiwan
New Taipei Clinical Site 1
New Taipei City, , Taiwan
Taichung Clinical Site 1
Taichung, , Taiwan
Taichung Clinical Site2
Taichung, , Taiwan
Tainan Clinical Site1
Tainan City, , Taiwan
Tainan Clinical Site2
Tainan City, , Taiwan
Taipei Clinical Site1
Taipei, , Taiwan
Taipei Clinical Site2
Taipei, , Taiwan
Taoyuan Clinical Site
Taoyuan District, , Taiwan
Countries
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References
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Boku N, Omori T, Shitara K, Sakuramoto S, Yamaguchi K, Kato K, Kadowaki S, Tsuji K, Ryu MH, Oh DY, Oh SC, Rha SY, Lee KW, Chung IJ, Sym SJ, Chen LT, Chen JS, Bai LY, Nakada T, Hagihara S, Makino R, Nishiyama E, Kang YK. Nivolumab plus chemotherapy in patients with HER2-negative, previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: 3-year follow-up of the ATTRACTION-4 randomized, double-blind, placebo-controlled, phase 3 trial. Gastric Cancer. 2024 Nov;27(6):1287-1301. doi: 10.1007/s10120-024-01535-0. Epub 2024 Aug 20.
Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.
Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.
Other Identifiers
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ONO-4538-37
Identifier Type: -
Identifier Source: org_study_id
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