Back to resultsA Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Primary Purpose
Gastric Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ONO-4538
Ipilimumab
Oxaliplatin
Capecitabine
S-1
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
- Participants who have a life expectancy of at least 3 months
Exclusion Criteria:
- Participants with a history or complications of multiple cancers
- Participants with a complication or history of severe hypersensitivity to any other antibody products
- Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
Sites / Locations
- National Cancer Center Hospital East
- Kanagawa Cancer Center
- Osaki Citizen Hospital
- Osaka University Hospital
- Saitama Medical University International Medical Center
- Saitama Cancer Center
- Shizuoka Cancer Center
- University of Tokyo Hospital
- National Cancer Center Hospital
- Cancer Institute Hospital of JFCR
- IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
- Keio University Hospital
- Chungbuk National University Hospital
- Kosin University Gospel Hospital
- Hallym University Sacred Heart Hospital
- National Cancer Center
- CHA Bundang Medical Center, CHA University
- Seoul National University Bundang Hospital
- The Catholic University of Korea, St. Vincent's Hospital
- Ajou University Hospital
- Kyungpook National University Chilgok Hospital
- Pusan National University Yangsan Hospital
- Jeonbuk national university hospital
- Chonnam National University Hwasun Hospital
- Dong-A University Hospital
- Inje University Haeundae Paik Hospital
- Pusan National University Hospital
- Keimyung University Dongsan Hospital
- Chungnam National University Hospital
- Konyang University Hospital
- Gachon University Gil Medical Center
- Asan Medical Center
- Chung-Ang University Hospital
- Gangnam Severance Hospital, Yonsei University Health System
- Kangbuk Samsung Hospital
- Korea University Guro Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Ulsan University Hospital
- Kaohsiung Chang Gung Memorial Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Chang Gung Memorial Hospital, Keelung
- Far Eastern Memorial Hospital
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
- China Medical University Hospital
- Taichung Veterans General Hospital
- Chi Mei Hospital, Liouying
- National Cheng Kung University Hospital
- Taipei Medical University Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- National Taiwan University Hospital
- Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital,Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ONO-4538 + ipilimumab + chemotherapy
Chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Overall survival (OS)
Secondary Outcome Measures
Progression-free survival (PFS) (site investigator assessment)
Objective response rate (ORR) (site investigator assessment)
Best overall response (BOR) (site investigator assessment)
Duration of response (DOR) (site investigator assessment)
Disease control rate (DCR) (site investigator assessment)
Time to response (TTR) (site investigator assessment)
Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
Adverse event
Full Information
NCT ID
NCT05144854
First Posted
October 6, 2021
Last Updated
September 1, 2023
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05144854
Brief Title
A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Official Title
A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
626 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ONO-4538 + ipilimumab + chemotherapy
Arm Type
Experimental
Arm Title
Chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ONO-4538
Other Intervention Name(s)
Nivolumab, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
Tegafur-gimeracil-oteracil potassium
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) (site investigator assessment)
Time Frame
up to 3 years
Title
Objective response rate (ORR) (site investigator assessment)
Time Frame
up to 3 years
Title
Best overall response (BOR) (site investigator assessment)
Time Frame
up to 3 years
Title
Duration of response (DOR) (site investigator assessment)
Time Frame
up to 3 years
Title
Disease control rate (DCR) (site investigator assessment)
Time Frame
up to 3 years
Title
Time to response (TTR) (site investigator assessment)
Time Frame
up to 3 years
Title
Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
Time Frame
up to 3 years
Title
Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
Time Frame
up to 3 years
Title
Adverse event
Time Frame
Up to 30 days after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
Participants who have a life expectancy of at least 3 months
Exclusion Criteria:
Participants with a history or complications of multiple cancers
Participants with a complication or history of severe hypersensitivity to any other antibody products
Participants with concurrent autoimmune disease or a 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
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Osaki Citizen Hospital
City
Osaki-shi
State/Province
Miyagi
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi
State/Province
Saitama
Country
Japan
Facility Name
Saitama Cancer Center
City
Ina-machi, Kitaadati-gun
State/Province
Saitama
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Nagaizumi-Cho, Sunto-Gun
State/Province
Shizuoka
Country
Japan
Facility Name
University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Keio University Hospital
City
Shinjyuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan-si
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Jeonbuk national university hospital
City
Jeonju-si
State/Province
Jeollabuk-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Keelung
City
Keelung City
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
Country
Taiwan
Facility Name
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
City
New Taipei City
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Chi Mei Hospital, Liouying
City
Tainan
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei City
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan County
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
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
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