Gastric CancerPhase 3NCT02267343
Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
A Phase 3 study testing ONO-4538 in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 49 sites in 3 countries.
Trial 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. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 493 participants
- Where
- 49 sitesin 3 countries
- Study dates
- Oct 2014to Jan 2021
- Phase
- Phase 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
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 3 countries.
49 sites in 3 countries
Japan28 sites
Hyogo Clinical Site
Akashi, Hyōgo, 673-8558
Tokyo Clinical Site
Bunkyo-ku, Tokyo, 113-8677
Chiba Clinical Site
Chiba, 260-8717
Tokyo Clinical Site
Chuo-ku, Tokyo, 104-0045
Fukuoka Clinical Site
Fukuoka, 811-1395
Fukuoka Clinical Site
Fukuoka, 812-8582
Gifu Clinical Site
Gifu, 501-1194
Hiroshima Clinical Site
Hiroshima, 730-8518
Ishikawa Clinical Site
Kanazawa, Ishikawa-ken, 920-8641
Kanagawa Clinical Site
Kawasaki, Kanagawa, 216-8511
Saitama Clinical Site
Kitaadachi, Saitama, 362-0806
Hyogo Clinical Site
Kobe, Hyōgo, 650-0047
Tokyo Clinical Site
Koto-ku, Tokyo, 135-8550
Ehime Clinical Site
Matsuyama, Ehime, 791-0280
Aomori Clinical Site
Misawa, Aomori, 033-0022
Aichi Clinical Site
Nagoya, Aichi-ken, 464-8681
Osaka Clinical Site
Osaka, 537-8511
Kanagawa Clinical Site
Sagamihara, Kanagawa, 252-0375
Nagano Clinical Site
Saku, Nagano, 385-0051
Hokkaido Clinical Site
Sapporo, Hokkaido, 060-8648
Osaka Clinical Site
Sayama, Osaka, 589-8511
Tochigi Clinical Site
Shimotsuke, Tochigi, 329-0498
Tokyo Clinical Site
Shinjuku-ku, Tokyo, 160-8582
Shizuoka Clinical Site
Shizuoka, 420-8527
Osaka Clinical Site
Suita, Osaka, 565-0871
Shizuoka Clinical Site
Sunto-gun, Shizuoka, 411-8777
Osaka Clinical Site
Takatsuki, Osaka, 569-8686
Kanagawa Clinical Site
Yokohama, Kanagawa, 241-8515
South Korea12 sites
Busan-si Clinical Site
Busan, 602-715
Daegu Clinical Site
Daegu, 702-210
Gyeonggi-Do Clinical Site
Gyeonggi-do, 410-769
Gyeonggi-Do Clinical Site
Gyeonggi-do, 463-707
Seoul Clinical Site
Seoul, 110-744
Seoul Clinical Site
Seoul, 120-752
Seoul Clinical Site
Seoul, 135-710
Seoul Clinical Site
Seoul, 135-720
Seoul Clinical Site
Seoul, 136-705
Seoul Clinical Site
Seoul, 137-701
Seoul Clinical Site
Seoul, 138-736
Seoul Clinical Site
Seoul, 152-703
Taiwan9 sites
Kaohsiung Clinical Site
Kaohsiung City, 807
Kaohsiung Clinical Site
Kaohsiung City, 833
Taichung Clinical Site
Taichung, 40447
Tainan Clinical Site
Tainan, 704
Taipei Clinical Site
Taipei, 10002
Taipei Clinical Site
Taipei, 112
Taipei Clinical Site
Taipei, 114
Taipei Clinical Site
Taipei, 116
Taoyuan Clinical Site
Taoyuan, 333
About this study
Official title: ONO-4538 Phase III Study A Multicenter, Double-Blind, 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 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
- Conditions
- Gastric Cancer
- Being tested
- ONO-4538, 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 Arm | Experimental | 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 Receives: Drug: ONO-4538 |
| Placebo Arm | Placebo comparator | Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Secondary outcomes (5)
Progression-free survival
Measured: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Objective response rate
Measured: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Duration of response
Measured: 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
Measured: Continuously throughout study treatment and up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Measured: Continuously throughout study treatment and 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 posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 493 participants (actual)
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
- NCT02267343
- Sponsor's protocol ID
- ONO-4538-12
- Status last verified
- May 2024
- First submitted
- 9 Oct 2014
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35383114Kang 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.
PubMed 28993052
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 III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT02267343
- Acronym / sponsor ID
- ONO-4538-12
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 17 Oct 2014 (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 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 Arm | Experimental | Drug: ONO-4538ONO-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 comparator | Drug: PlaceboPlacebo intravenously every 2 weeks 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 (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 Arm |
| Placebo | Drug | Placebo Arm |
Primary outcome
Overall survival
Time frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
5 secondary outcomes
Progression-free survival
Time frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Objective response rate
Time frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Duration of response
Time frame: 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
Time frame: Continuously throughout study treatment and up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time frame: Continuously throughout study treatment and 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 35383114Kang 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.
- Derived from this study: PubMed 28993052Kang 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.
- 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.
49 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONO-4538 in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 49 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 6 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 49 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 phase mean?
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?
Overall survival (time frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle). 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 NCT02267343, which also lists 2 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; AzTrials last refreshed its copy on 7 Nov 2026.