ONO-4578
DrugONO-4578 will be administered to participants at a specified dose once daily.
NCT Number: NCT07818070
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
Participants will:
* Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy. * Make visits to the clinic for checkups and tests. * Answer questions about their health throughout the trial.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria apply.
ONO-4578 will be administered to participants at a specified dose once daily.
Matching placebo for ONO-4578 will be administered to participants once daily.
Nivolumab will be administered to participants at a specified dose on specified days.
Oxaliplatin will be administered to participants at a specified dose on specified days.
Capecitabine will be administered to participants at a specified dose on specified days.
S-1 will be administered to participants at a specified dose on specified days.
Fluorouracil will be administered to participants at a specified dose on specified days.
Leucovorin Calcium will be administered to participants at a specified dose on specified days.
Levoleucovorin will be administered to participants at a specified dose on specified days.
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Contact information is provided by the study sponsor or research team.
Ono Pharmaceutical Co., Ltd.
Industry
A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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