Back to resultsStudy of ONO-4538 in Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-4538
Oxaliplatin
Tegafur- Gimeracil-Oteracil potassium
Capecitabine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
- 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 multiple cancers
- 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
Sites / Locations
- Aichi Clinical Site
- Aomori Clinical Site
- Aomori Clinical Site
- Chiba Clinical Site
- Chiba Clinical Site
- Chiba Clinical Site
- Ehime Clinical Site1
- Ehime Clinical Site2
- Fukuoka Clinical Site
- Fukuoka Clinical Site1
- Fukuoka Clinical Site2
- Fukuoka Clinical Site
- Gifu Clinical Site
- Gifu Clinical Site
- Gumma Clinical Site
- Gumma Clinical Site
- Gunma Clinical Site
- Hiroshima Clinical Site
- Hokkaido Clinical Site
- Hokkaido Clinical Site4
- Hokkaido Clinical Site1
- Hokkaido Clinical Site2
- Hokkaido Clinical Site3
- Hyogo Clinical Site
- Hyogo Clinical Site
- Hyogo Clinical Site
- Hyogo Clinical Site
- Ibaraki Clinical Site
- Ibaraki Clinical Site
- Ishikawa Clinical Site1
- Ishikawa Clinical Site2
- Iwate Clinical Site
- Kagawa Clinical Site
- Kanagawa Clinical Site
- Kanagawa Clinical Site
- Kanagawa Clinical Site
- Kanagawa Clinical Site1
- Kanagawa Clinical Site2
- Kanagawa Clinical Site3
- Miyagi Clinical Site
- Miyagi Clinical Site
- Miyagi Clinical Site
- Nagano Clinical Site
- Nara Clinical Site
- Nara Clinical Site
- Okayama Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Saitama Clinical Site
- Saitama Clinical Site
- Shizuoka Clinical Site
- Tochigi Clinical Site
- Tochigi Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site1
- Tokyo Clinical Site2
- Tokyo Clinical Site
- Tottori Clinical Site
- Yamagata Clinical Site
- Akita Clinical Site
- Chiba Clinical Site1
- Chiba Clinical Site2
- Fukui Clinical Site
- Fukuoka Clinical Site1
- Fukuoka Clinical Site2
- Fukuoka Clinical Site3
- Fukuoka Clinical Site4
- Fukushima Clinical Site
- Hiroshima Clinical Site1
- Hiroshima Clinical Site2
- Hiroshima Clinical Site3
- Kumamoto Clinical Site1
- Kumamoto Clinical Site2
- Kumamoto Clinical Site3
- Kyoto Clinical Site1
- Kyoto Clinical Site2
- Kyoto Clinical Site3
- Niigata Clinical Site
- Okayama Clinical Site
- Osaka Clinical Site1
- Osaka Clinical Site2
- Osaka Clinical Site3
- Osaka Clinical Site4
- Shizuoka Clinical Site
- Tokushima Clinical Site
- Toyama Clinical Site
- Wakayama Clinical Site
- Yamagata Clinical Site
- Busan Clinical Site
- Daegu Clinical Site 1
- Daegu Clinical Site 2
- Daejeon Clinical Site
- Gyeonggi-Do Clinical Site1
- Gyeonggi-Do Clinical Site2
- Gyeonggi-Do Clinical Site3
- Gyeonggi-Do Clinical Site4
- Gyeonggi-Do Clinical Site5
- Gyeongnam Clinical Site
- Incheon Clinical Site
- Jeollabuk-Do Clinical Site
- Jeollanam-do Clinical Site
- Seoul Clinical Site 1
- Seoul Clinical Site 2
- Seoul Clinical Site 3
- Seoul Clinical Site 4
- Seoul Clinical Site 5
- Seoul Clinical Site 6
- Seoul Clinical Site7
- Seoul Clinical Site8
- Seoul Clinical Site9
- Ulsan Clinical Site
- Kaohsiung Clinical Site1
- Kaohsiung Clinical Site2
- New Taipei Clinical Site 1
- Taichung Clinical Site 1
- Taichung Clinical Site2
- Tainan Clinical Site1
- Tainan Clinical Site2
- Taipei Clinical Site1
- Taipei Clinical Site2
- Taoyuan Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ONO-4538 + SOX Therapy Cohort (Part 1)
ONO-4538 + CapeOX Therapy Cohort (Part 1)
ONO-4538 + chemotherapy group (Part 2)
Placebo + Chemotherapy group (Part 2)
Arm Description
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 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.
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.
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.
Outcomes
Primary Outcome Measures
Progression-free survival (central assessment by IRRC) (only Part 2)
Overall survival (only Part 2)
Secondary Outcome Measures
Objective response rate (only Part 2)
Progression-free survival (assessment by the site investigator)(only Part 2)
Duration of response (only Part 2)
Disease control rate (only Part 2)
Time to response (only Part 2)
Best overall response (only Part 2)
Percent change in the sum of diameters of target lesions (only Part 2)
Safety will be analyzed through the incidence of adverse events, serious adverse events
Safety will be analyzed through the incidence of laboratory abnormalities
Full Information
NCT ID
NCT02746796
First Posted
March 29, 2016
Last Updated
April 20, 2022
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02746796
Brief Title
Study of ONO-4538 in Gastric Cancer
Official Title
ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ONO-4538 + SOX Therapy Cohort (Part 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
ONO-4538 + CapeOX Therapy Cohort (Part 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
ONO-4538 + chemotherapy group (Part 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Chemotherapy group (Part 2)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ONO-4538
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Tegafur- Gimeracil-Oteracil potassium
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Progression-free survival (central assessment by IRRC) (only Part 2)
Time Frame
Up to study completion (estimated time frame: 48 months)
Title
Overall survival (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Secondary Outcome Measure Information:
Title
Objective response rate (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Progression-free survival (assessment by the site investigator)(only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Duration of response (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Disease control rate (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Time to response (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Best overall response (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Percent change in the sum of diameters of target lesions (only Part 2)
Time Frame
Up to study completion (estimated time frame: 54 months)
Title
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time Frame
Up to 28 days from last dose
Title
Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame
Up to 28 days from last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
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 multiple cancers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsunobu Tanimoto
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Clinical Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Aomori Clinical Site
City
Hirosaki
State/Province
Aomori
Country
Japan
Facility Name
Aomori Clinical Site
City
Misawa
State/Province
Aomori
Country
Japan
Facility Name
Chiba Clinical Site
City
Funabashi
State/Province
Chiba
Country
Japan
Facility Name
Chiba Clinical Site
City
Kamogawa
State/Province
Chiba
Country
Japan
Facility Name
Chiba Clinical Site
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Ehime Clinical Site1
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Ehime Clinical Site2
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site1
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site2
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Gifu Clinical Site
City
Gifu-shi
State/Province
Gifu
Country
Japan
Facility Name
Gifu Clinical Site
City
Ogaki
State/Province
Gifu
Country
Japan
Facility Name
Gumma Clinical Site
City
Maebashi
State/Province
Gumma
Country
Japan
Facility Name
Gumma Clinical Site
City
Takasaki
State/Province
Gumma
Country
Japan
Facility Name
Gunma Clinical Site
City
Ota
State/Province
Gunma
Country
Japan
Facility Name
Hiroshima Clinical Site
City
Kure
State/Province
Hiroshima
Country
Japan
Facility Name
Hokkaido Clinical Site
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site4
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site3
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hyogo Clinical Site
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Ibaraki Clinical Site
City
Higashiibaraki-gun
State/Province
Ibaraki
Country
Japan
Facility Name
Ibaraki Clinical Site
City
Tsuchiura-shi
State/Province
Ibaraki
Country
Japan
Facility Name
Ishikawa Clinical Site1
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Ishikawa Clinical Site2
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Iwate Clinical Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Kagawa Clinical Site
City
Kita-gun
State/Province
Kagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site1
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site2
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site3
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Miyagi Clinical Site
City
Natori
State/Province
Miyagi
Country
Japan
Facility Name
Miyagi Clinical Site
City
Osaki
State/Province
Miyagi
Country
Japan
Facility Name
Miyagi Clinical Site
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Nagano Clinical Site
City
Saku
State/Province
Nagano
Country
Japan
Facility Name
Nara Clinical Site
City
Ikoma
State/Province
Nara
Country
Japan
Facility Name
Nara Clinical Site
City
Kashihara-shi
State/Province
Nara
Country
Japan
Facility Name
Okayama Clinical Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Osaka Clinical Site
City
Izumi
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Takatsuki
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Toyonaka
State/Province
Osaka
Country
Japan
Facility Name
Saitama Clinical Site
City
Hidaka
State/Province
Saitama
Country
Japan
Facility Name
Saitama Clinical Site
City
Kitaadachi-gun
State/Province
Saitama
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Tochigi Clinical Site
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Tochigi Clinical Site
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
Tokyo Clinical Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Fuchu
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site1
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site2
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Tottori Clinical Site
City
Yonago
State/Province
Tottori
Country
Japan
Facility Name
Yamagata Clinical Site
City
Sakata
State/Province
Yamagata
Country
Japan
Facility Name
Akita Clinical Site
City
Akita
Country
Japan
Facility Name
Chiba Clinical Site1
City
Chiba
Country
Japan
Facility Name
Chiba Clinical Site2
City
Chiba
Country
Japan
Facility Name
Fukui Clinical Site
City
Fukui
Country
Japan
Facility Name
Fukuoka Clinical Site1
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site2
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site3
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site4
City
Fukuoka
Country
Japan
Facility Name
Fukushima Clinical Site
City
Fukushima
Country
Japan
Facility Name
Hiroshima Clinical Site1
City
Hiroshima
Country
Japan
Facility Name
Hiroshima Clinical Site2
City
Hiroshima
Country
Japan
Facility Name
Hiroshima Clinical Site3
City
Hiroshima
Country
Japan
Facility Name
Kumamoto Clinical Site1
City
Kumamoto
Country
Japan
Facility Name
Kumamoto Clinical Site2
City
Kumamoto
Country
Japan
Facility Name
Kumamoto Clinical Site3
City
Kumamoto
Country
Japan
Facility Name
Kyoto Clinical Site1
City
Kyoto
Country
Japan
Facility Name
Kyoto Clinical Site2
City
Kyoto
Country
Japan
Facility Name
Kyoto Clinical Site3
City
Kyoto
Country
Japan
Facility Name
Niigata Clinical Site
City
Niigata
Country
Japan
Facility Name
Okayama Clinical Site
City
Okayama
Country
Japan
Facility Name
Osaka Clinical Site1
City
Osaka
Country
Japan
Facility Name
Osaka Clinical Site2
City
Osaka
Country
Japan
Facility Name
Osaka Clinical Site3
City
Osaka
Country
Japan
Facility Name
Osaka Clinical Site4
City
Osaka
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Shizuoka
Country
Japan
Facility Name
Tokushima Clinical Site
City
Tokushima
Country
Japan
Facility Name
Toyama Clinical Site
City
Toyama
Country
Japan
Facility Name
Wakayama Clinical Site
City
Wakayama
Country
Japan
Facility Name
Yamagata Clinical Site
City
Yamagata
Country
Japan
Facility Name
Busan Clinical Site
City
Busan
Country
Korea, Republic of
Facility Name
Daegu Clinical Site 1
City
Daegu
Country
Korea, Republic of
Facility Name
Daegu Clinical Site 2
City
Daegu
Country
Korea, Republic of
Facility Name
Daejeon Clinical Site
City
Daejeon
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site1
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site2
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site3
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site4
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site5
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Gyeongnam Clinical Site
City
Gyeongnam
Country
Korea, Republic of
Facility Name
Incheon Clinical Site
City
Incheon
Country
Korea, Republic of
Facility Name
Jeollabuk-Do Clinical Site
City
Jeollabuk-Do
Country
Korea, Republic of
Facility Name
Jeollanam-do Clinical Site
City
Jeollanam-do
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 1
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 2
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 3
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 4
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 5
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 6
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site7
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site8
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site9
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan Clinical Site
City
Ulsan
Country
Korea, Republic of
Facility Name
Kaohsiung Clinical Site1
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Clinical Site2
City
Kaohsiung
Country
Taiwan
Facility Name
New Taipei Clinical Site 1
City
New Taipei
Country
Taiwan
Facility Name
Taichung Clinical Site 1
City
Taichung
Country
Taiwan
Facility Name
Taichung Clinical Site2
City
Taichung
Country
Taiwan
Facility Name
Tainan Clinical Site1
City
Tainan
Country
Taiwan
Facility Name
Tainan Clinical Site2
City
Tainan
Country
Taiwan
Facility Name
Taipei Clinical Site1
City
Taipei
Country
Taiwan
Facility Name
Taipei Clinical Site2
City
Taipei
Country
Taiwan
Facility Name
Taoyuan Clinical Site
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html
Citations:
PubMed Identifier
35030335
Citation
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.
Results Reference
derived
PubMed Identifier
30566590
Citation
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.
Results Reference
derived
Learn more about this trial
Study of ONO-4538 in Gastric Cancer
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