Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07818070

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Have advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma that has been histologically confirmed to be predominant adenocarcinoma.
  • Have not been treated with systemic anticancer agents for advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
  • Participants who have received neoadjuvant or adjuvant therapy may be included if no residual tumors are found after surgery (R0 resection) and if the therapy was completed at least 180 days before the date of recurrence.
  • Have measurable or nonmeasurable disease, as defined in Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1, and documented on computed tomography (CT) or magnetic resonance imaging (MRI) images within 42 days before Cycle 1 Day 1 (C1D1).
  • Tumor programmed cell death ligand 1 (PD-L1) expression must be confirmed as combined positive score (CPS ≥1) prior to randomization.
  • Participant must be able to provide tissues samples for analyses.

Key Exclusion Criteria:

  • Participants with Human epidermal growth factor 2 (HER2)-positive or indeterminate gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma as determined by local testing. Determination for HER2 positivity is made based on the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry (IHC), or 2+ by IHC and positive by in situ hybridization.
  • Participants whose tumors have known microsatellite instability-high or mismatch repair-deficient status.
  • Marked malnutrition requiring continuous enteral nutrition or intravenous hyperalimentation, or continuous infusion therapy with hospitalization.
  • Active autoimmune disease, or history of autoimmune disease that might recur, that may affect vital organ function, or that may require immune-suppressive treatment, including systemic corticosteroids.
  • Participants with vitiligo, type 1 diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled.

Other protocol-defined inclusion and exclusion criteria apply.

Treatment and study plan

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 4 years

  2. Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

    Time frame: Up to approximately 4 years

Secondary outcomes

  1. PFS per Investigator Assessment

    Time frame: Up to approximately 4 years

  2. Objective Response Rate (ORR) per BICR

    Time frame: Up to approximately 4 years

  3. Duration of Response (DOR) per BICR

    Time frame: Up to approximately 4 years

  4. Disease Control Rate (DCR) per BICR

    Time frame: Up to approximately 4 years

  5. Time to Response (TTR) per BICR

    Time frame: Up to approximately 4 years

  6. PFS After the Next-line of Therapy (PFS2) per Investigator Assessment

    Time frame: Up to approximately 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Team

CONTACT

[email protected]

888-724-3274

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Deciphera Pharmaceuticals, LLC

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

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.

Published trials that share one or more normalized conditions with this study.