Clinical trial NCT05144854: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 626
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Progression-free survival (PFS) (site investigator assessment)
timeFrame: up to 3 years
measure: Objective response rate (ORR) (site investigator assessment)
timeFrame: up to 3 years
measure: Best overall response (BOR) (site investigator assessment)
timeFrame: up to 3 years
measure: Duration of response (DOR) (site investigator assessment)
timeFrame: up to 3 years
measure: Disease control rate (DCR) (site investigator assessment)
timeFrame: up to 3 years
measure: Time to response (TTR) (site investigator assessment)
timeFrame: up to 3 years
measure: Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
timeFrame: up to 3 years
measure: Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
timeFrame: up to 3 years
measure: Adverse event
timeFrame: Up to 30 days after the last dose
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Osaki-shi
country: Japan
facility: Osaki Citizen Hospital
state: Miyagi
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Ina-machi, Kitaadati-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Nagaizumi-Cho, Sunto-Gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: University of Tokyo Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
city: Minato-ku
country: Japan
facility: IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Gangwon-do
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Gyeongsangbuk-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk national university hospital
state: Jeollabuk-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Keelung City
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital,Linkou
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: