Gastric CancerPhase 2/3NCT02746796
Study of ONO-4538 in Gastric Cancer
A Phase 2/3 study testing ONO-4538, Oxaliplatin and Tegafur- Gimeracil-Oteracil potassium in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 130 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- ONO-4538, Oxaliplatin and Tegafur- Gimeracil-Oteracil potassium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 680 participants
- Where
- 130 sitesin 3 countries
- Study dates
- Mar 2016to 17 Nov 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
130 sites in 3 countries.
130 sites in 3 countries
Japan97 sites
Hyogo Clinical Site
Akashi, Hyōgo
Akita Clinical Site
Akita
Hyogo Clinical Site
Amagasaki, Hyōgo
Tokyo Clinical Site
Bunkyo-ku, Tokyo
Chiba Clinical Site1
Chiba
Chiba Clinical Site2
Chiba
Tokyo Clinical Site
Chuo-ku, Tokyo
Tokyo Clinical Site
Fuchū, Tokyo
Fukui Clinical Site
Fukui
Fukuoka Clinical Site1
Fukuoka
Fukuoka Clinical Site2
Fukuoka
Fukuoka Clinical Site3
Fukuoka
Fukuoka Clinical Site4
Fukuoka
Fukushima Clinical Site
Fukushima
Chiba Clinical Site
Funabashi, Chiba
Gifu Clinical Site
Gifu, Gifu
Hokkaido Clinical Site
Hakodate, Hokkaido
Shizuoka Clinical Site
Hamamatsu, Shizuoka
Saitama Clinical Site
Hidaka, Saitama
Ibaraki Clinical Site
Higashiibaraki-gun, Ibaraki
Aomori Clinical Site
Hirosaki, Aomori
Hiroshima Clinical Site1
Hiroshima
Hiroshima Clinical Site2
Hiroshima
Hiroshima Clinical Site3
Hiroshima
Fukuoka Clinical Site
Iizuka, Fukuoka
Nara Clinical Site
Ikoma, Nara
Kanagawa Clinical Site
Isehara, Kanagawa
Osaka Clinical Site
Izumi, Osaka
Kanagawa Clinical Site
Kamakura, Kanagawa
Chiba Clinical Site
Kamogawa, Chiba
Ishikawa Clinical Site1
Kanazawa, Ishikawa-ken
Ishikawa Clinical Site2
Kanazawa, Ishikawa-ken
Nara Clinical Site
Kashihara-shi, Nara
Chiba Clinical Site
Kashiwa, Chiba
Kagawa Clinical Site
Kita-gun, Kagawa-ken
Saitama Clinical Site
Kitaadachi-gun, Saitama
Fukuoka Clinical Site1
Kitakyushu, Fukuoka
Fukuoka Clinical Site2
Kitakyushu, Fukuoka
Hyogo Clinical Site
Kobe, Hyōgo
Tokyo Clinical Site
Koto-ku, Tokyo
Kumamoto Clinical Site1
Kumamoto
Kumamoto Clinical Site2
Kumamoto
Kumamoto Clinical Site3
Kumamoto
Okayama Clinical Site
Kurashiki, Okayama-ken
Hiroshima Clinical Site
Kure, Hiroshima
Fukuoka Clinical Site
Kurume, Fukuoka
Kyoto Clinical Site1
Kyoto
Kyoto Clinical Site2
Kyoto
Kyoto Clinical Site3
Kyoto
Gumma Clinical Site
Maebashi, Gunma
Ehime Clinical Site1
Matsuyama, Ehime
Ehime Clinical Site2
Matsuyama, Ehime
Tokyo Clinical Site
Minato-ku, Tokyo
Aomori Clinical Site
Misawa, Aomori
Iwate Clinical Site
Morioka, Iwate
Aichi Clinical Site
Nagoya, Aichi-ken
Miyagi Clinical Site
Natori-shi, Miyagi
Niigata Clinical Site
Niigata
Hyogo Clinical Site
Nishinomiya, Hyōgo
Gifu Clinical Site
Ōgaki, Gifu
Okayama Clinical Site
Okayama
Osaka Clinical Site1
Osaka
Osaka Clinical Site2
Osaka
Osaka Clinical Site3
Osaka
Osaka Clinical Site4
Osaka
Miyagi Clinical Site
Ōsaki, Miyagi
Gunma Clinical Site
Ōta, Gunma
Kanagawa Clinical Site
Sagamihara, Kanagawa
Osaka Clinical Site
Sakai, Osaka
Yamagata Clinical Site
Sakata, Yamagata
Nagano Clinical Site
Saku, Nagano
Hokkaido Clinical Site1
Sapporo, Hokkaido
Hokkaido Clinical Site2
Sapporo, Hokkaido
Hokkaido Clinical Site3
Sapporo, Hokkaido
Hokkaido Clinical Site4
Sapporo, Hokkaido
Osaka Clinical Site
Sayama, Osaka
Miyagi Clinical Site
Sendai, Miyagi
Tochigi Clinical Site
Shimotsuke, Tochigi
Tokyo Clinical Site
Shinagawa-ku, Tokyo
Tokyo Clinical Site1
Shinjuku-ku, Tokyo
Tokyo Clinical Site2
Shinjuku-ku, Tokyo
Shizuoka Clinical Site
Shizuoka
Osaka Clinical Site
Suita, Osaka
Tokyo Clinical Site
Tachikawa, Tokyo
Gumma Clinical Site
Takasaki, Gunma
Osaka Clinical Site
Takatsuki, Osaka
Tokushima Clinical Site
Tokushima
Toyama Clinical Site
Toyama
Osaka Clinical Site
Toyonaka, Osaka
Ibaraki Clinical Site
Tsuchiura-shi, Ibaraki
Tochigi Clinical Site
Utsunomiya, Tochigi
Wakayama Clinical Site
Wakayama
Yamagata Clinical Site
Yamagata
Kanagawa Clinical Site1
Yokohama, Kanagawa
Kanagawa Clinical Site2
Yokohama, Kanagawa
Kanagawa Clinical Site3
Yokohama, Kanagawa
Tottori Clinical Site
Yonago, Tottori
South Korea23 sites
Busan Clinical Site
Busan
Daegu Clinical Site 1
Daegu
Daegu Clinical Site 2
Daegu
Daejeon Clinical Site
Daejeon
Gyeonggi-Do Clinical Site1
Gyeonggi-do
Gyeonggi-Do Clinical Site2
Gyeonggi-do
Gyeonggi-Do Clinical Site3
Gyeonggi-do
Gyeonggi-Do Clinical Site4
Gyeonggi-do
Gyeonggi-Do Clinical Site5
Gyeonggi-do
Gyeongnam Clinical Site
Gyeongnam, Gyeongsangnam-do
Incheon Clinical Site
Incheon
Jeollabuk-Do Clinical Site
Jeollabuk-Do
Jeollanam-do Clinical Site
Jeollanam-do
Seoul Clinical Site 1
Seoul
Seoul Clinical Site 2
Seoul
Seoul Clinical Site 3
Seoul
Seoul Clinical Site 4
Seoul
Seoul Clinical Site 5
Seoul
Seoul Clinical Site 6
Seoul
Seoul Clinical Site7
Seoul
Seoul Clinical Site8
Seoul
Seoul Clinical Site9
Seoul
Ulsan Clinical Site
Ulsan
Taiwan10 sites
Kaohsiung Clinical Site1
Kaohsiung City
Kaohsiung Clinical Site2
Kaohsiung City
New Taipei Clinical Site 1
New Taipei City
Taichung Clinical Site 1
Taichung
Taichung Clinical Site2
Taichung
Tainan Clinical Site1
Tainan
Tainan Clinical Site2
Tainan
Taipei Clinical Site1
Taipei
Taipei Clinical Site2
Taipei
Taoyuan Clinical Site
Taoyuan
About this study
Official title: ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
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.
- Conditions
- Gastric Cancer
- Being tested
- ONO-4538, Oxaliplatin, Tegafur- Gimeracil-Oteracil potassium, Capecitabine, Placebo
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
OxaliplatinDrug
Tegafur- Gimeracil-Oteracil potassiumDrug
CapecitabineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 + SOX Therapy Cohort (Part 1) | Experimental | 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. Receives: Drug: ONO-4538; Drug: Oxaliplatin; Drug: Tegafur- Gimeracil-Oteracil potassium |
| ONO-4538 + CapeOX Therapy Cohort (Part 1) | Experimental | 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. Receives: Drug: ONO-4538; Drug: Oxaliplatin; Drug: Capecitabine |
| ONO-4538 + chemotherapy group (Part 2) | Experimental | 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. Receives: Drug: ONO-4538; Drug: Oxaliplatin; Drug: Tegafur- Gimeracil-Oteracil potassium; Drug: Capecitabine |
| Placebo + Chemotherapy group (Part 2) | Placebo comparator | 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. Receives: Drug: Oxaliplatin; Drug: Tegafur- Gimeracil-Oteracil potassium; Drug: Capecitabine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (central assessment by IRRC) (only Part 2)
Measured: Up to study completion (estimated time frame: 48 months)
Overall survival (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Secondary outcomes (9)
Objective response rate (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Progression-free survival (assessment by the site investigator)(only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Duration of response (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Disease control rate (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Time to response (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Best overall response (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Percent change in the sum of diameters of target lesions (only Part 2)
Measured: Up to study completion (estimated time frame: 54 months)
Safety will be analyzed through the incidence of adverse events, serious adverse events
Measured: Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Measured: Up to 28 days from last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2020
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsunobu Tanimoto, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746796
- Sponsor's protocol ID
- ONO-4538-37
- Status last verified
- May 2024
- First submitted
- 29 Mar 2016
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen LT, Kang YK, Ryu MH, Oh DY, Oh SC, Rha SY, 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 in Asian people with advanced or recurrent stomach or gastroesophageal junction cancer (ATTRACTION-4 study): a plain language summary. Future Oncol. 2026 Mar;22(6):625-642. doi: 10.1080/14796694.2026.2622806. Epub 2026 Mar 1.
PubMed 41766168Boku 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.
PubMed 39162872Kang 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.
PubMed 35030335Boku 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.
PubMed 30566590
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT02746796
- Acronym / sponsor ID
- ONO-4538-37
- Conditions
- Gastric Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 + SOX Therapy Cohort (Part 1) | Experimental | Drug: ONO-4538, Drug: Oxaliplatin, Drug: Tegafur- Gimeracil-Oteracil potassiumONO-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 + CapeOX Therapy Cohort (Part 1) | Experimental | Drug: ONO-4538, Drug: Oxaliplatin, Drug: CapecitabineONO-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 + chemotherapy group (Part 2) | Experimental | Drug: ONO-4538, Drug: Oxaliplatin, Drug: Tegafur- Gimeracil-Oteracil potassium, Drug: CapecitabineWith 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. |
| Placebo + Chemotherapy group (Part 2) | Placebo comparator | Drug: Oxaliplatin, Drug: Tegafur- Gimeracil-Oteracil potassium, Drug: Capecitabine, Drug: PlaceboWith 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538 | Drug | ONO-4538 + CapeOX Therapy Cohort (Part 1), ONO-4538 + SOX Therapy Cohort (Part 1), ONO-4538 + chemotherapy group (Part 2) |
| Oxaliplatin | Drug | ONO-4538 + CapeOX Therapy Cohort (Part 1), ONO-4538 + SOX Therapy Cohort (Part 1), ONO-4538 + chemotherapy group (Part 2), Placebo + Chemotherapy group (Part 2) |
| Tegafur- Gimeracil-Oteracil potassium | Drug | ONO-4538 + SOX Therapy Cohort (Part 1), ONO-4538 + chemotherapy group (Part 2), Placebo + Chemotherapy group (Part 2) |
| Capecitabine | Drug | ONO-4538 + CapeOX Therapy Cohort (Part 1), ONO-4538 + chemotherapy group (Part 2), Placebo + Chemotherapy group (Part 2) |
| Placebo | Drug | Placebo + Chemotherapy group (Part 2) |
Primary outcome
Progression-free survival (central assessment by IRRC) (only Part 2)
Time frame: Up to study completion (estimated time frame: 48 months)
Overall survival (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
9 secondary outcomes
Objective response rate (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Progression-free survival (assessment by the site investigator)(only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Duration of response (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Disease control rate (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Time to response (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Best overall response (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Percent change in the sum of diameters of target lesions (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time frame: Up to 28 days from last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41766168Chen LT, Kang YK, Ryu MH, Oh DY, Oh SC, Rha SY, 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 in Asian people with advanced or recurrent stomach or gastroesophageal junction cancer (ATTRACTION-4 study): a plain language summary. Future Oncol. 2026 Mar;22(6):625-642. doi: 10.1080/14796694.2026.2622806. Epub 2026 Mar 1.
- Derived from this study: PubMed 39162872Boku 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.
- Derived from this study: PubMed 35030335Kang 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.
- Derived from this study: PubMed 30566590Boku 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitsunobu Tanimoto study director
Ono Pharmaceutical Co., Ltd.
130 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ONO-4538, Oxaliplatin and Tegafur- Gimeracil-Oteracil potassium in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 130 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (central assessment by IRRC) (only Part 2) (time frame: Up to study completion (estimated time frame: 48 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746796, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.