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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)

NCT05144854

Active Not RecruitingPhase 3

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Gastric Cancer

Interventions: ONO-4538, Ipilimumab, Oxaliplatin, Capecitabine, S-1

Countries: Japan, South Korea, Taiwan

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 overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (57)

Kashiwa-shi, Chiba, Japan
Yokohama, Kanagawa, Japan
Osaki-shi, Miyagi, Japan
Suita-shi, Osaka, Japan
Hidaka-shi, Saitama, Japan
Ina-machi, Kitaadati-gun, Saitama, Japan
Nagaizumi-Cho, Sunto-Gun, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinjyuku-ku, Tokyo, Japan
Busan, Gangwon-do, South Korea
Anyang-si, Gyeonggi-do, South Korea
Goyang-si, Gyeonggi-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Suwon, Gyeonggi-do, South Korea
Suwon, Gyeonggi-do, South Korea
Daegu, Gyeongsangbuk-do, South Korea
Yangsan, Gyeongsangnam-do, South Korea
Jeonju, Jeollabuk-do, South Korea
Hwasun-gun, Jeollanam-do, South Korea
Cheongju-si, North Chungcheong, South Korea
Busan, South Korea
Busan, South Korea
Busan, South Korea
Daegu, South Korea
Daejeon, South Korea
Daejeon, South Korea
+ 27 more on CT.gov