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Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Tegafur-gimeracil-oteracil potassium
Oxaliplatin
Capecitabine
Placebo
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Anhui Province Clinical Site
  • Beijing Clinical Site1
  • Beijing Clinical Site2
  • Cuangdong Province Clinical Site
  • Guangdong Province Clinical Site1
  • Guangdong Province Clinical Site2
  • Henan Province Clinical Site1
  • Henan Province Clinical Site2
  • Jiangsu Province Clinical Site1
  • Jiangsu Province Clinical Site3
  • Jiangsu Province Clinical Site4
  • Jiangsu Province Clinical Site5
  • Jiangsu Province Clinical Site6
  • Jiangxi Province Clinical Site2
  • Jilin Province Clinical Site
  • Liaoning Province Clinical Site
  • Shanxi Province Clinical Site
  • Tianjin Clinical Site1
  • Tianjin Clinical Site2
  • Zhejiang Province Clinical Site
  • Zhengjiang Province Clinical Site
  • Aichi Clinical Site1
  • Aichi Clinical Site2
  • Chiba Clinical Site
  • Ehime Clinical Site
  • Ehime Clinicla Site
  • Gifu Clinical Site
  • Gunma Clinical Site
  • Gunma Clinical Site
  • Hiroshima Clinical Site
  • Hokkaido Clinical Site 3
  • Hokkaido Clinical Site 1
  • Hokkaido Clinical Site2
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Ishikawa Clinical Site
  • Iwate Clinical Site
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site
  • Miyagi Clinical Site
  • Nagano 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
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Chiba Clinical Site
  • Fukuoka Clinical Site 1
  • Fukuoka Clinical Site 2
  • Gifu Clinical Site
  • Hiroshima Clinical Site1
  • Hiroshima Clinical Site2
  • Hiroshima Clinical Site3
  • Kochi Clinical Site
  • Kumamoto Clinical Site
  • Kyoto Clinical Site
  • Niigata Clinical Site
  • Osaka Clinical Site1
  • Osaka Clinical Site2
  • Osaka Clinical Site3
  • Osaka Clinical Site4
  • Shizuoka Clinical Site
  • Toyama Clinical Site
  • Wakayama Clinical Site
  • Yamagata Clinical Site
  • Busan Clinical Site1
  • Busan Clinical Site2
  • Busan Clinical Site3
  • Daegu Clinical Site1
  • Daegu Clinical Site2
  • Daegu Clinical Site3
  • Daejeon Clinical Site 1
  • Daejeon Clinical Site 2
  • Gwangju Clinical Site
  • Gyeonggi-do Clinical Site1
  • Gyeonggi-do Clinical Site2
  • Gyeonggi-do Clinical Site3
  • Gyeonggi-do Clinical Site4
  • Gyeonggi-do Clinical Site5
  • Jeollabuk-do Clinical Site
  • Seoul Clinical Site 8
  • Seoul Clinical Site 9
  • Seoul Clinical Site1
  • Seoul Clinical Site2
  • Seoul Clinical Site3
  • Seoul Clinical Site4
  • Seoul Clinical Site5
  • Seoul Clinical Site6
  • Seoul Clinical Site7
  • Kaohsiung Clinical Site2
  • Kaohsiung Clinical Site
  • New Taipei Clinical Site
  • Taichung Clinical Site
  • Tainan Clinical Site2
  • Tainan Clinical Site
  • Taipei Clinical Site1
  • Taipei Clinical Site2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nivolumab group

Placebo group

Arm Description

Nivolumab: 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.

Placebo: 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.

Outcomes

Primary Outcome Measures

Relapse-free survival (RFS)

Secondary Outcome Measures

Overall survival (OS)
3-year OS rate
5-year OS rate
3-year RFS rate
5-year RFS rate
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

First Posted
December 27, 2016
Last Updated
July 4, 2023
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03006705
Brief Title
Study of Adjuvant ONO-4538 With Resected Gastric Cancer
Official Title
A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab group
Arm Type
Experimental
Arm Description
Nivolumab: 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo: 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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, ONO-4538, MDX-1106
Intervention Description
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Intervention Type
Drug
Intervention Name(s)
Tegafur-gimeracil-oteracil potassium
Intervention Description
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Primary Outcome Measure Information:
Title
Relapse-free survival (RFS)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
5 years
Title
3-year OS rate
Time Frame
3 years
Title
5-year OS rate
Time Frame
5 years
Title
3-year RFS rate
Time Frame
3 years
Title
5-year RFS rate
Time Frame
5 years
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
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Province Clinical Site
City
Anhui Province
Country
China
Facility Name
Beijing Clinical Site1
City
Beijing
Country
China
Facility Name
Beijing Clinical Site2
City
Beijing
Country
China
Facility Name
Cuangdong Province Clinical Site
City
Cuangdong Province
Country
China
Facility Name
Guangdong Province Clinical Site1
City
Guangdong Province
Country
China
Facility Name
Guangdong Province Clinical Site2
City
Guangdong Province
Country
China
Facility Name
Henan Province Clinical Site1
City
Henan Province
Country
China
Facility Name
Henan Province Clinical Site2
City
Henan Province
Country
China
Facility Name
Jiangsu Province Clinical Site1
City
Jiangsu Province
Country
China
Facility Name
Jiangsu Province Clinical Site3
City
Jiangsu Province
Country
China
Facility Name
Jiangsu Province Clinical Site4
City
Jiangsu Province
Country
China
Facility Name
Jiangsu Province Clinical Site5
City
Jiangsu Province
Country
China
Facility Name
Jiangsu Province Clinical Site6
City
Jiangsu Province
Country
China
Facility Name
Jiangxi Province Clinical Site2
City
Jiangxi Province
Country
China
Facility Name
Jilin Province Clinical Site
City
Jilin Province
Country
China
Facility Name
Liaoning Province Clinical Site
City
Liaoning Province
Country
China
Facility Name
Shanxi Province Clinical Site
City
Shanxi Province
Country
China
Facility Name
Tianjin Clinical Site1
City
Tianjin
Country
China
Facility Name
Tianjin Clinical Site2
City
Tianjin
Country
China
Facility Name
Zhejiang Province Clinical Site
City
Zhejiang Province
Country
China
Facility Name
Zhengjiang Province Clinical Site
City
Zhengjiang Province
Country
China
Facility Name
Aichi Clinical Site1
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Aichi Clinical Site2
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Chiba Clinical Site
City
Kamogawa
State/Province
Chiba
Country
Japan
Facility Name
Ehime Clinical Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Ehime Clinicla Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Gifu Clinical Site
City
Ōgaki
State/Province
Gifu
Country
Japan
Facility Name
Gunma Clinical Site
City
Ota
State/Province
Gunma
Country
Japan
Facility Name
Gunma Clinical Site
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Hiroshima Clinical Site
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Hokkaido Clinical Site 3
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site 1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site2
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
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Ishikawa Clinical Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Iwate Clinical Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Miyagi Clinical Site
City
Osaki
State/Province
Miyagi
Country
Japan
Facility Name
Nagano Clinical Site
City
Saku
State/Province
Nagano
Country
Japan
Facility Name
Okayama Clinical Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Osaka Clinical Site
City
Hirakata
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
Osaka Clinical Site
City
Ōsaka-sayama
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
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Tochigi Clinical Site
City
Shimotsuke
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
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Chiba Clinical Site
City
Chiba
Country
Japan
Facility Name
Fukuoka Clinical Site 1
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site 2
City
Fukuoka
Country
Japan
Facility Name
Gifu Clinical Site
City
Gifu
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
Kochi Clinical Site
City
Kochi
Country
Japan
Facility Name
Kumamoto Clinical Site
City
Kumamoto
Country
Japan
Facility Name
Kyoto Clinical Site
City
Kyoto
Country
Japan
Facility Name
Niigata Clinical Site
City
Niigata
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
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 Site1
City
Busan
Country
Korea, Republic of
Facility Name
Busan Clinical Site2
City
Busan
Country
Korea, Republic of
Facility Name
Busan Clinical Site3
City
Busan
Country
Korea, Republic of
Facility Name
Daegu Clinical Site1
City
Daegu
Country
Korea, Republic of
Facility Name
Daegu Clinical Site2
City
Daegu
Country
Korea, Republic of
Facility Name
Daegu Clinical Site3
City
Daegu
Country
Korea, Republic of
Facility Name
Daejeon Clinical Site 1
City
Daejeon
Country
Korea, Republic of
Facility Name
Daejeon Clinical Site 2
City
Daejeon
Country
Korea, Republic of
Facility Name
Gwangju Clinical Site
City
Gwangju
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
Jeollabuk-do Clinical Site
City
Jeollabuk-do
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 8
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 9
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site1
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site2
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site3
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site4
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site5
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site6
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site7
City
Seoul
Country
Korea, Republic of
Facility Name
Kaohsiung Clinical Site2
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
Country
Taiwan
Facility Name
New Taipei Clinical Site
City
New Taipei
Country
Taiwan
Facility Name
Taichung Clinical Site
City
Taichung
Country
Taiwan
Facility Name
Tainan Clinical Site2
City
Tainan
Country
Taiwan
Facility Name
Tainan Clinical Site
City
Tainan
Country
Taiwan
Facility Name
Taipei Clinical Site1
City
Taipei
Country
Taiwan
Facility Name
Taipei Clinical Site2
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono-pharma.com/en/company/policies/clinical_trial_data_transparency_policy.html
Citations:
PubMed Identifier
35623069
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Adjuvant ONO-4538 With Resected Gastric Cancer

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