A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

December 6, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

July 31, 2027

Conditions
Gastric Cancer
Interventions
DRUG

ONO-4578

Specified dose, once daily

DRUG

Oxaliplatin

Specified dose on specified days

DRUG

Capecitabine

Specified dose on specified days

DRUG

S-1

Specified dose on specified days

DRUG

Nivolumab

Specified dose on specified days

DRUG

Placebo

Specified dose, once daily

Trial Locations (63)

Unknown

Aichi Cancer Center Hospital, Nagoya

National Cancer Center Hospital East, Kashiwa-shi

Matsuyama Red Cross Hospital, Matsuyama

NHO Shikoku Cancer Center, Matsuyama

Kyushu University Hospital, Fukuoka

NHO Kyushu Cancer Center, Fukuoka

JCHO Kyushu Hospital, Yahatanishi-ku, Kitakyusyu-shi

Gunma Prefectural Cancer Center, Ota-shi

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

Hyogo Cancer Center, Akashi-shi

JOHAS Kansai Rosai Hospital, Amagasaki-shi

Kobe City Hospital Organization Kobe City Medical Center General Hospital, Kobe

Ibaraki Prefectural Central Hospital, Kasama-shi

Ishikawa Prefectural Central Hospital, Kanazawa

Iwate Medical University Hospital, Yahaba-cho, Shiwa-gun

Kagawa University Hospital, Miki-cho, Kita-gun

Kitasato University Hospital, Sagamihara-shi

Kanagawa Cancer Center, Yokohama

Osaki Citizen Hospital, Osaki-shi

Tohoku University Hospital, Sendai

Kurashiki Central Hospital, Kurashiki-shi

Osaka International Cancer Institute, Chuo-ku

Kansai Medical University Hospital, Hirakata-shi

Kindai University Hospital, Sayama-shi

Osaka General Medical Center, Sumiyoshi-ku

Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi

Saitama Cancer Center, Ina-machi, Kitaadati-gun

Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun

Cancer Institute Hospital of JFCR, Koto-ku

IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Minato-Ku

Keio University Hospital, Shinjuku-ku

Osaka Metropolitan University Hospital, Osaka

Kosin University Gospel Hospital, Busan

Hallym University Sacred Heart Hospital, Anyang-si

National Cancer Center, Goyang-si

CHA Bundang Medical Center, CHA University, Seongnam-si

Seoul National University Bundang Hospital, Seongnam-si

Ajou University Hospital, Suwon

The Catholic University of Korea, St. Vincent's Hospital, Suwon

Pusan National University Yangsan Hospital, Yangsan

Jeonbuk national university hospital, Jeonju

Chonnam National University Hwasun Hospital, Hwasun-gun

Chungbuk National University Hospital, Cheongju-si

Dong-A University Hospital, Busan

Keimyung University Dongsan Hospital, Daegu

Kyungpook National University Chilgok Hospital, Daegu

Yeungnam University Hospital, Daegu

Gachon University Gil Medical Center, Incheon

Inha University Hospital, Incheon

Asan Medical Center, Seoul

Kangbuk Samsung Hospital, Seoul

Korea University Guro Hospital, Seoul

Kyung Hee University Hospital, Seoul

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University Health System, Seoul

The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul

Ulsan University Hospital, Ulsan

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

China Medical University Hospital, Taichung

Chi Mei Hospital, Liouying, Tainan City

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Chang Gung Memorial Hospital, Linkou, Taoyuan District

Sponsors
All Listed Sponsors
lead

Ono Pharmaceutical Co. Ltd

INDUSTRY