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)

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05144854
• Other study ID #: ONO-4538-113
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 5, 2021
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 626
• Est. completion date: May 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma

2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1

3. Participants who have a life expectancy of at least 3 months

Exclusion Criteria:

1. Participants with a history or complications of multiple cancers

2. Participants with a complication or history of severe hypersensitivity to any other antibody products

3. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• ONO-4538
Specified dose on specified days
• Ipilimumab
Specified dose on specified days
• Oxaliplatin
Specified dose on specified days
• Capecitabine
Specified dose on specified days
• S-1
Specified dose on specified days

Locations

Country	Name	City	State
Japan	University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center	Hidaka-shi	Saitama
Japan	Saitama Cancer Center	Ina-machi, Kitaadati-gun	Saitama
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	Cancer Institute Hospital of JFCR	Koto-ku	Tokyo
Japan	IMSUT Hospital, The Institute of Medical Science, The University of Tokyo	Minato-ku	Tokyo
Japan	Shizuoka Cancer Center	Nagaizumi-Cho, Sunto-Gun	Shizuoka
Japan	Osaki Citizen Hospital	Osaki-shi	Miyagi
Japan	Keio University Hospital	Shinjyuku-ku	Tokyo
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Kanagawa Cancer Center	Yokohama-shi	Kanagawa
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan	Gangwon-do
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Gyeongsangbuk-do
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Jeonbuk national university hospital	Jeonju-si	Jeollabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongsangnam-do
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital, Keelung	Keelung City
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Hospital, Liouying	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Municipal Wanfang Hospital Managed by Taipei Medical University	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital,Linkou	Taoyuan County

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		up to 3 years
Secondary	Progression-free survival (PFS) (site investigator assessment)		up to 3 years
Secondary	Objective response rate (ORR) (site investigator assessment)		up to 3 years
Secondary	Best overall response (BOR) (site investigator assessment)		up to 3 years
Secondary	Duration of response (DOR) (site investigator assessment)		up to 3 years
Secondary	Disease control rate (DCR) (site investigator assessment)		up to 3 years
Secondary	Time to response (TTR) (site investigator assessment)		up to 3 years
Secondary	Maximum percent change in the sum diameters of the target lesions (site investigator assessment)		up to 3 years
Secondary	Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)		up to 3 years
Secondary	Adverse event		Up to 30 days after the last dose