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)
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT06256328
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo+Nivolumab+chemotherapy Capecitabine - placebo+Nivolumab+chemotherapy Placebo - ONO-4578+Nivolumab+chemotherapy ONO-4578 - ONO-4578+Nivolumab+chemotherapy Oxaliplatin - placebo+Nivolumab+chemotherapy Nivolumab - ONO-4578+Nivolumab+chemotherapy Nivolumab - ONO-4578+Nivolumab+chemotherapy Capecitabine - ONO-4578+Nivolumab+chemotherapy S-1 - placebo+Nivolumab+chemotherapy Oxaliplatin - placebo+Nivolumab+chemotherapy S-1 -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) (site investigator assessment) up to 2years
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) (site investigator assessment) up to 2years Overall survival (OS) up to 2years Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) up to 2years Adverse event (AE) Up to 30 days after the last dose Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Best overall response (BOR) (site investigator assessment) up to 2years Duration of response (DOR) (site investigator assessment) up to 2years Disease control rate (DCR) (site investigator assessment) up to 2years Time to response (TTR) (site investigator assessment) up to 2years Maximum percent change in the sum diameters of the target lesions (site investigator assessment) up to 2years
Related Research Topics
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Trial Locations
- Locations (63)
Aichi Cancer Center Hospital
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Matsuyama Red Cross Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
NHO Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
NHO Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
JCHO Kyushu Hospital
🇯🇵Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Hyogo Cancer Center
🇯🇵Akashi-shi, Hyogo, Japan
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