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.
Study ID
NCT07818070
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Esophageal Adenocarcinoma
  • Esophagogastric Junction Cancer
  • Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONO-4578 — DRUG
    ONO-4578 will be administered to participants at a specified dose once daily.
  • Placebo — OTHER
    Matching placebo for ONO-4578 will be administered to participants once daily.
  • Nivolumab — DRUG
    Nivolumab will be administered to participants at a specified dose on specified days.
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered to participants at a specified dose on specified days.
  • Capecitabine — DRUG
    Capecitabine will be administered to participants at a specified dose on specified days.
  • Tegafur-gimeracil-oteracil potassium (S-1) — DRUG
    S-1 will be administered to participants at a specified dose on specified days.
  • Fluorouracil — DRUG
    Fluorouracil will be administered to participants at a specified dose on specified days.
  • Leucovorin Calcium — DRUG
    Leucovorin Calcium will be administered to participants at a specified dose on specified days.
  • Levoleucovorin — DRUG
    Levoleucovorin will be administered to participants at a specified dose on specified days.

Study Details

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.

Key Dates

First listed
Sep 14, 2026
Start date
Feb 28, 2027
Status verified
Sep 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2031

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-4578 + Nivolumab + Chemotherapy
    Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
  • Active Comparator: Placebo + Nivolumab + Chemotherapy
    Participants will receive placebo and chemotherapy, which will include some of the listed agents.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]

Central Contacts

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