Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
1 other identifier
interventional
493
3 countries
49
Brief Summary
The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
Started Oct 2014
Typical duration for phase_3 gastric-cancer
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMay 3, 2024
May 1, 2024
1.8 years
October 9, 2014
May 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Secondary Outcomes (5)
Progression-free survival
Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Objective response rate
Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Duration of response
Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Safety will be analyzed through the incidence of adverse events, serious adverse events
Continuously throughout study treatment and up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Continuously throughout study treatment and up to 28 days from last dose
Study Arms (2)
ONO-4538 Arm
EXPERIMENTALONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Placebo Arm
PLACEBO COMPARATORPlacebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Interventions
Eligibility Criteria
You may qualify if:
- Men \& women ≥20 years of age
- 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
You may not qualify if:
- Current or past history of severe hypersensitivity to any other antibody products
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Aichi Clinical Site
Nagoya, Aichi-ken, 464-8681, Japan
Aomori Clinical Site
Misawa, Aomori, 033-0022, Japan
Ehime Clinical Site
Matsuyama, Ehime, 791-0280, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Clinical Site
Akashi, Hyōgo, 673-8558, Japan
Hyogo Clinical Site
Kobe, Hyōgo, 650-0047, Japan
Ishikawa Clinical Site
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa Clinical Site
Kawasaki, Kanagawa, 216-8511, Japan
Kanagawa Clinical Site
Sagamihara, Kanagawa, 252-0375, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, 241-8515, Japan
Nagano Clinical Site
Saku, Nagano, 385-0051, Japan
Osaka Clinical Site
Sayama, Osaka, 589-8511, Japan
Osaka Clinical Site
Suita, Osaka, 565-0871, Japan
Osaka Clinical Site
Takatsuki, Osaka, 569-8686, Japan
Saitama Clinical Site
Kitaadachi, Saitama, 362-0806, Japan
Shizuoka Clinical Site
Sunto-gun, Shizuoka, 411-8777, Japan
Tochigi Clinical Site
Shimotsuke, Tochigi, 329-0498, Japan
Tokyo Clinical Site
Bunkyo-ku, Tokyo, 113-8677, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, 104-0045, Japan
Tokyo Clinical Site
Koto-ku, Tokyo, 135-8550, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, 160-8582, Japan
Chiba Clinical Site
Chiba, 260-8717, Japan
Fukuoka Clinical Site
Fukuoka, 811-1395, Japan
Fukuoka Clinical Site
Fukuoka, 812-8582, Japan
Gifu Clinical Site
Gifu, 501-1194, Japan
Hiroshima Clinical Site
Hiroshima, 730-8518, Japan
Osaka Clinical Site
Osaka, 537-8511, Japan
Shizuoka Clinical Site
Shizuoka, 420-8527, Japan
Busan-si Clinical Site
Busan, 602-715, South Korea
Daegu Clinical Site
Daegu, 702-210, South Korea
Gyeonggi-Do Clinical Site
Gyeonggi-do, 410-769, South Korea
Gyeonggi-Do Clinical Site
Gyeonggi-do, 463-707, South Korea
Seoul Clinical Site
Seoul, 110-744, South Korea
Seoul Clinical Site
Seoul, 120-752, South Korea
Seoul Clinical Site
Seoul, 135-710, South Korea
Seoul Clinical Site
Seoul, 135-720, South Korea
Seoul Clinical Site
Seoul, 136-705, South Korea
Seoul Clinical Site
Seoul, 137-701, South Korea
Seoul Clinical Site
Seoul, 138-736, South Korea
Seoul Clinical Site
Seoul, 152-703, South Korea
Kaohsiung Clinical Site
Kaohsiung City, 807, Taiwan
Kaohsiung Clinical Site
Kaohsiung City, 833, Taiwan
Taichung Clinical Site
Taichung, 40447, Taiwan
Tainan Clinical Site
Tainan, 704, Taiwan
Taipei Clinical Site
Taipei, 10002, Taiwan
Taipei Clinical Site
Taipei, 112, Taiwan
Taipei Clinical Site
Taipei, 114, Taiwan
Taipei Clinical Site
Taipei, 116, Taiwan
Taoyuan Clinical Site
Taoyuan District, 333, Taiwan
Related Publications (2)
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.
PMID: 35383114DERIVEDKang 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.
PMID: 28993052DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mitsunobu Tanimoto
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
October 17, 2014
Study Start
October 1, 2014
Primary Completion
August 1, 2016
Study Completion
January 1, 2021
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share