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NOT YET RECRUITING
NCT07818070
PHASE3

A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma

Sponsor: Ono Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2027-02

Completion Date

2031-01

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

ONO-4578

ONO-4578 will be administered to participants at a specified dose once daily.

OTHER

Placebo

Matching placebo for ONO-4578 will be administered to participants once daily.

DRUG

Nivolumab

Nivolumab will be administered to participants at a specified dose on specified days.

DRUG

Oxaliplatin

Oxaliplatin will be administered to participants at a specified dose on specified days.

DRUG

Capecitabine

Capecitabine will be administered to participants at a specified dose on specified days.

DRUG

Tegafur-gimeracil-oteracil potassium (S-1)

S-1 will be administered to participants at a specified dose on specified days.

DRUG

Fluorouracil

Fluorouracil will be administered to participants at a specified dose on specified days.

DRUG

Leucovorin Calcium

Leucovorin Calcium will be administered to participants at a specified dose on specified days.

DRUG

Levoleucovorin

Levoleucovorin will be administered to participants at a specified dose on specified days.