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)

Trial Title: 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)

NCT ID: NCT06256328

Condition: Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Tegafur
Nivolumab
Oxaliplatin

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Drug
Intervention name: ONO-4578
Description: Specified dose, once daily
Arm group label: ONO-4578+Nivolumab+chemotherapy

Intervention type: Drug
Intervention name: Oxaliplatin
Description: Specified dose on specified days
Arm group label: ONO-4578+Nivolumab+chemotherapy
Arm group label: placebo+Nivolumab+chemotherapy

Intervention type: Drug
Intervention name: Capecitabine
Description: Specified dose on specified days
Arm group label: ONO-4578+Nivolumab+chemotherapy
Arm group label: placebo+Nivolumab+chemotherapy

Intervention type: Drug
Intervention name: S-1
Description: Specified dose on specified days
Arm group label: ONO-4578+Nivolumab+chemotherapy
Arm group label: placebo+Nivolumab+chemotherapy

Other name: Tegafur-gimeracil-oteracil potassium

Intervention type: Drug
Intervention name: Nivolumab
Description: Specified dose on specified days
Arm group label: ONO-4578+Nivolumab+chemotherapy
Arm group label: placebo+Nivolumab+chemotherapy

Other name: Opdivo

Intervention type: Drug
Intervention name: Placebo
Description: Specified dose, once daily
Arm group label: placebo+Nivolumab+chemotherapy

Summary: This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma - Patients have not been treated with systemic chemotherapy as first-line therapy - Patients who can provide tumor tissue samples Exclusion Criteria: - Patients unable to take oral medicines - Patients with HER2-positive - Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine - Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment - Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis - Patients with headache and/or nausea associated with brain metastasis

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Aichi Cancer Center Hospital

Address:
City: Nagoya-shi
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Country: Japan

Facility:
Name: Matsuyama Red Cross Hospital

Address:
City: Matsuyama-shi
Country: Japan

Facility:
Name: NHO Shikoku Cancer Center

Address:
City: Matsuyama-shi
Country: Japan

Facility:
Name: Kyushu University Hospital

Address:
City: Fukuoka-shi
Country: Japan

Facility:
Name: NHO Kyushu Cancer Center

Address:
City: Fukuoka-shi
Country: Japan

Facility:
Name: JCHO Kyushu Hospital

Address:
City: Yahatanishi-ku, Kitakyusyu-shi
Country: Japan

Facility:
Name: Gunma Prefectural Cancer Center

Address:
City: Ota-shi
Country: Japan

Facility:
Name: Hiroshima City Hiroshima Citizens Hospital

Address:
City: Hiroshima-shi
Country: Japan

Facility:
Name: Hyogo Cancer Center

Address:
City: Akashi-shi
Country: Japan

Facility:
Name: Kobe City Hospital Organization Kobe City Medical Center General Hospital

Address:
City: Kobe-shi
Country: Japan

Facility:
Name: JOHAS Kansai Rosai Hospital

Address:
City: Amagasaki-shi
Country: Japan

Facility:
Name: Ibaraki Prefectural Central Hospital

Address:
City: Kasama-shi
Country: Japan

Facility:
Name: Ishikawa Prefectural Central Hospital

Address:
City: Kanazawa-shi
Country: Japan

Facility:
Name: Iwate Medical University Hospital

Address:
City: Yahaba-cho, Shiwa-gun
Country: Japan

Facility:
Name: Kagawa University Hospital

Address:
City: Miki-cho, Kita-gun
Country: Japan

Facility:
Name: Kitasato University Hospital

Address:
City: Sagamihara-shi
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Yokohama-shi
Country: Japan

Facility:
Name: Osaki Citizen Hospital

Address:
City: Osaki-shi
Country: Japan

Facility:
Name: Tohoku University Hospital

Address:
City: Sendai-shi
Country: Japan

Facility:
Name: Kurashiki Central Hospital

Address:
City: Kurashiki-shi
Country: Japan

Facility:
Name: Osaka International Cancer Institute

Address:
City: Chuo-ku
Country: Japan

Facility:
Name: Kansai Medical University Hospital

Address:
City: Hirakata-shi
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Sayama-shi
Country: Japan

Facility:
Name: Osaka General Medical Center

Address:
City: Sumiyoshi-ku
Country: Japan

Facility:
Name: Osaka Medical and Pharmaceutical University Hospital

Address:
City: Takatsuki-shi
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Ina-machi, Kitaadati-gun
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Nagaizumi-cho, Sunto-gun
Country: Japan

Facility:
Name: Cancer Institute Hospital of JFCR

Address:
City: Koto-ku
Country: Japan

Facility:
Name: IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

Address:
City: Minato-Ku
Country: Japan

Facility:
Name: Keio University Hospital

Address:
City: Shinjuku-ku
Country: Japan

Facility:
Name: Osaka Metropolitan University Hospital

Address:
City: Osaka
Country: Japan

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Country: Korea, Republic of

Facility:
Name: Kosin University Gospel Hospital

Address:
City: Busan
Country: Korea, Republic of

Facility:
Name: Hallym University Sacred Heart Hospital

Address:
City: Anyang-si
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Country: Korea, Republic of

Facility:
Name: CHA Bundang Medical Center, CHA University

Address:
City: Seongnam-si
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, St. Vincent's Hospital

Address:
City: Suwon-si
Country: Korea, Republic of

Facility:
Name: Ajou University Hospital

Address:
City: Suwon
Country: Korea, Republic of

Facility:
Name: Pusan National University Yangsan Hospital

Address:
City: Yangsan-si
Country: Korea, Republic of

Facility:
Name: Jeonbuk national university hospital

Address:
City: Jeonju-si
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Hwasun-gun
Country: Korea, Republic of

Facility:
Name: Dong-A University Hospital

Address:
City: Busan
Country: Korea, Republic of

Facility:
Name: Keimyung University Dongsan Hospital

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Yeungnam University Hospital

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Gachon University Gil Medical Center

Address:
City: Incheon
Country: Korea, Republic of

Facility:
Name: Inha University Hospital

Address:
City: Incheon
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Kangbuk Samsung Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Korea University Guro Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Kyung Hee University Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Ulsan University Hospital

Address:
City: Ulsan
Country: Korea, Republic of

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Country: Taiwan

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Country: Taiwan

Facility:
Name: Chi Mei Hospital, Liouying

Address:
City: Tainan
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Country: Taiwan

Facility:
Name: Chang Gung Memorial Hospital, Linkou

Address:
City: Taoyuan
Country: Taiwan

Start date: December 6, 2023

Completion date: July 31, 2027

Lead sponsor:
Agency: Ono Pharmaceutical Co. Ltd
Agency class: Industry

Source: Ono Pharmaceutical Co. Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06256328