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Gastric CancerPhase 3NCT03006705

Study of Adjuvant ONO-4538 With Resected Gastric Cancer

A Phase 3 study testing Nivolumab, Tegafur-gimeracil-oteracil potassium and Oxaliplatin in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 108 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
Nivolumab, Tegafur-gimeracil-oteracil potassium and Oxaliplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
108 sitesin 4 countries
Study dates
31 Jan 2017to 31 Mar 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed adenocarcinoma of the stomach
  • Patients without a remnant cancer (R0) who have undergone gastrectomy
  • Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Who cannot join

  • Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
  • Multiple primary cancers
  • A current or past history of severe hypersensitivity to any other antibody products
  • Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease

Trial locations and contacts

108 sites in 4 countries.

108 sites in 4 countries

Japan55 sites

  • Hyogo Clinical Site

    Akashi, Hyōgo

  • Hyogo Clinical Site

    Amagasaki, Hyōgo

  • Tokyo Clinical Site

    Bunkyo-ku, Tokyo

  • Chiba Clinical Site

    Chiba

  • Tokyo Clinical Site

    Chuo-ku, Tokyo

  • Fukuoka Clinical Site 1

    Fukuoka

  • Fukuoka Clinical Site 2

    Fukuoka

  • Hiroshima Clinical Site

    Fukuyama, Hiroshima

  • Gifu Clinical Site

    Gifu

  • Hokkaido Clinical Site 3

    Hakodate, Hokkaido

  • Saitama Clinical Site

    Hidaka, Saitama

  • Osaka Clinical Site

    Hirakata, Osaka

  • Hiroshima Clinical Site1

    Hiroshima

  • Hiroshima Clinical Site2

    Hiroshima

  • Hiroshima Clinical Site3

    Hiroshima

  • Chiba Clinical Site

    Kamogawa, Chiba

  • Ishikawa Clinical Site

    Kanazawa, Ishikawa-ken

  • Saitama Clinical Site

    Kitaadachi-gun, Saitama

  • Kochi Clinical Site

    Kochi

  • Tokyo Clinical Site

    Koto-ku, Tokyo

  • Kumamoto Clinical Site

    Kumamoto

  • Okayama Clinical Site

    Kurashiki, Okayama-ken

  • Kyoto Clinical Site

    Kyoto

  • Ehime Clinical Site

    Matsuyama, Ehime

  • Ehime Clinicla Site

    Matsuyama, Ehime

  • Iwate Clinical Site

    Morioka, Iwate

  • Aichi Clinical Site1

    Nagoya, Aichi-ken

  • Aichi Clinical Site2

    Nagoya, Aichi-ken

  • Niigata Clinical Site

    Niigata

  • Hyogo Clinical Site

    Nishinomiya, Hyōgo

  • Gifu Clinical Site

    Ōgaki, Gifu

  • Osaka Clinical Site1

    Osaka

  • Osaka Clinical Site2

    Osaka

  • Osaka Clinical Site3

    Osaka

  • Osaka Clinical Site4

    Osaka

  • Osaka Clinical Site

    Ōsaka-sayama, Osaka

  • Miyagi Clinical Site

    Ōsaki, Miyagi

  • Gunma Clinical Site

    Ōta, Gunma

  • Kanagawa Clinical Site

    Sagamihara, Kanagawa

  • Osaka Clinical Site

    Sakai, Osaka

  • Nagano Clinical Site

    Saku, Nagano

  • Hokkaido Clinical Site 1

    Sapporo, Hokkaido

  • Hokkaido Clinical Site2

    Sapporo, Hokkaido

  • Tochigi Clinical Site

    Shimotsuke, Tochigi

  • Tokyo Clinical Site

    Shinjuku-ku, Tokyo

  • Shizuoka Clinical Site

    Shizuoka

  • Osaka Clinical Site

    Suita, Osaka

  • Shizuoka Clinical Site

    Sunto-gun, Shizuoka

  • Gunma Clinical Site

    Takasaki, Gunma

  • Osaka Clinical Site

    Takatsuki, Osaka

  • Toyama Clinical Site

    Toyama

  • Osaka Clinical Site

    Toyonaka, Osaka

  • Wakayama Clinical Site

    Wakayama

  • Yamagata Clinical Site

    Yamagata

  • Kanagawa Clinical Site

    Yokohama, Kanagawa

Other trials in Japan

South Korea24 sites

  • Busan Clinical Site1

    Busan

  • Busan Clinical Site2

    Busan

  • Busan Clinical Site3

    Busan

  • Daegu Clinical Site1

    Daegu

  • Daegu Clinical Site2

    Daegu

  • Daegu Clinical Site3

    Daegu

  • Daejeon Clinical Site 1

    Daejeon

  • Daejeon Clinical Site 2

    Daejeon

  • Gwangju Clinical Site

    Gwangju

  • 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

  • Jeollabuk-do Clinical Site

    Jeollabuk-do

  • Seoul Clinical Site 8

    Seoul

  • Seoul Clinical Site 9

    Seoul

  • Seoul Clinical Site1

    Seoul

  • Seoul Clinical Site2

    Seoul

  • Seoul Clinical Site3

    Seoul

  • Seoul Clinical Site4

    Seoul

  • Seoul Clinical Site5

    Seoul

  • Seoul Clinical Site6

    Seoul

  • Seoul Clinical Site7

    Seoul

Other trials in South Korea

China21 sites

  • Anhui Province Clinical Site

    Anhui Province

  • Beijing Clinical Site1

    Beijing

  • Beijing Clinical Site2

    Beijing

  • Cuangdong Province Clinical Site

    Cuangdong Province

  • Guangdong Province Clinical Site1

    Guangdong Province

  • Guangdong Province Clinical Site2

    Guangdong Province

  • Henan Province Clinical Site1

    Henan Province

  • Henan Province Clinical Site2

    Henan Province

  • Jiangsu Province Clinical Site1

    Jiangsu Province

  • Jiangsu Province Clinical Site3

    Jiangsu Province

  • Jiangsu Province Clinical Site4

    Jiangsu Province

  • Jiangsu Province Clinical Site5

    Jiangsu Province

  • Jiangsu Province Clinical Site6

    Jiangsu Province

  • Jiangxi Province Clinical Site2

    Jiangxi Province

  • Jilin Province Clinical Site

    Jilin Province

  • Liaoning Province Clinical Site

    Liaoning Province

  • Shanxi Province Clinical Site

    Shanxi Province

  • Tianjin Clinical Site1

    Tianjin

  • Tianjin Clinical Site2

    Tianjin

  • Zhejiang Province Clinical Site

    Zhejiang Province

  • Zhengjiang Province Clinical Site

    Zhengjiang Province

Other trials in China

Taiwan8 sites

  • Kaohsiung Clinical Site2

    Kaohsiung City

  • Kaohsiung Clinical Site

    Kaohsiung City

  • New Taipei Clinical Site

    New Taipei City

  • Taichung Clinical Site

    Taichung

  • Tainan Clinical Site2

    Tainan

  • Tainan Clinical Site

    Tainan

  • Taipei Clinical Site1

    Taipei

  • Taipei Clinical Site2

    Taipei

Other trials in Taiwan

About this study

Official title: A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.

Conditions
Gastric Cancer
Being tested
Nivolumab, Tegafur-gimeracil-oteracil potassium, Oxaliplatin, Capecitabine, Placebo
Keywords
ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called BMS-936558, ONO-4538, MDX-1106

    Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

  • Tegafur-gimeracil-oteracil potassiumDrug

    Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.

  • CapecitabineDrug

    Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

  • PlaceboDrug

    Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Study groups in NCT03006705
Study groupRoleWhat they receive
Nivolumab groupExperimentalNivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Receives: Drug: Nivolumab; Drug: Tegafur-gimeracil-oteracil potassium; Drug: Oxaliplatin; Drug: Capecitabine
Placebo groupPlacebo comparatorPlacebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Receives: Drug: Tegafur-gimeracil-oteracil potassium; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free survival (RFS)

    Measured: 5 years

Secondary outcomes (7)

  1. Overall survival (OS)

    Measured: 5 years

  2. 3-year OS rate

    Measured: 3 years

  3. 5-year OS rate

    Measured: 5 years

  4. 3-year RFS rate

    Measured: 3 years

  5. 5-year RFS rate

    Measured: 5 years

  6. Safety will be analyzed through the incidence of adverse events, serious adverse events

    Measured: Up to 28 days from last dose

  7. 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.

  1. First posted30 Dec 2016 (estimated)
  2. Study start31 Jan 2017
  3. Primary completion17 Aug 2022
  4. Study completion31 Mar 2023

Resources

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
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03006705
Sponsor's protocol ID
ONO-4538-38
Status last verified
May 2024
First submitted
27 Dec 2016
Last updated
3 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kang YK, Terashima M, Kim YW, Boku N, Chung HC, Chen JS, Ji J, Yeh TS, Chen LT, Ryu MH, Kim JG, Omori T, Rha SY, Kim TY, Ryu KW, Sakuramoto S, Nishida Y, Fukushima N, Yamada T, Bai LY, Hirashima Y, Hagihara S, Nakada T, Sasako M. Adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy for stage III gastric or gastro-oesophageal junction cancer after gastrectomy with D2 or more extensive lymph-node dissection (ATTRACTION-5): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):705-717. doi: 10.1016/S2468-1253(24)00156-0. Epub 2024 Jun 18.

    PubMed 38906161

  • Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

    PubMed 35623069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Tegafur-gimeracil-oteracil potassium and Oxaliplatin in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 108 sites in 4 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 108 sites in Japan, South Korea, China, 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?

Relapse-free survival (RFS) (time frame: 5 years). 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 NCT03006705, 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.

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