Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
NCT ID: NCT02267343
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
493 participants
INTERVENTIONAL
2014-10-31
2021-01-31
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 Arm
ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
ONO-4538
Placebo Arm
Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Placebo
Interventions
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ONO-4538
Placebo
Eligibility Criteria
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Inclusion Criteria
* Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)
* Histologically confirmed adenocarcinoma
* Refractory to or intolerant of standard therapy
* ECOG Performance Status score 0 or 1
* A life expectancy of at least 3 months
Exclusion Criteria
* Patients with multiple primary cancers
* 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
Misawa, Aomori, Japan
Ehime Clinical Site
Matsuyama, Ehime, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, Japan
Hyogo Clinical Site
Akashi, Hyōgo, Japan
Hyogo Clinical Site
Kobe, Hyōgo, Japan
Ishikawa Clinical Site
Kanazawa, Ishikawa-ken, Japan
Kanagawa Clinical Site
Kawasaki, Kanagawa, Japan
Kanagawa Clinical Site
Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, Japan
Nagano Clinical Site
Saku, Nagano, Japan
Osaka Clinical Site
Sayama, Osaka, Japan
Osaka Clinical Site
Suita, Osaka, Japan
Osaka Clinical Site
Takatsuki, Osaka, Japan
Saitama Clinical Site
Kitaadachi, Saitama, Japan
Shizuoka Clinical Site
Sunto-gun, Shizuoka, Japan
Tochigi Clinical Site
Shimotsuke, Tochigi, Japan
Tokyo Clinical Site
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site
Koto-ku, Tokyo, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, Japan
Chiba Clinical Site
Chiba, , Japan
Fukuoka Clinical Site
Fukuoka, , Japan
Fukuoka Clinical Site
Fukuoka, , Japan
Gifu Clinical Site
Gifu, , Japan
Hiroshima Clinical Site
Hiroshima, , Japan
Osaka Clinical Site
Osaka, , Japan
Shizuoka Clinical Site
Shizuoka, , Japan
Busan-si Clinical Site
Busan, , South Korea
Daegu Clinical Site
Daegu, , South Korea
Gyeonggi-Do Clinical Site
Gyeonggi-do, , South Korea
Gyeonggi-Do Clinical Site
Gyeonggi-do, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Kaohsiung Clinical Site
Kaohsiung City, , Taiwan
Kaohsiung Clinical Site
Kaohsiung City, , Taiwan
Taichung Clinical Site
Taichung, , Taiwan
Tainan Clinical Site
Tainan City, , Taiwan
Taipei Clinical Site
Taipei, , Taiwan
Taipei Clinical Site
Taipei, , Taiwan
Taipei Clinical Site
Taipei, , Taiwan
Taipei Clinical Site
Taipei, , Taiwan
Taoyuan Clinical Site
Taoyuan District, , Taiwan
Countries
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References
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Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.
Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.
Other Identifiers
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ONO-4538-12
Identifier Type: -
Identifier Source: org_study_id
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