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NCT Number: NCT05144854

A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
  • Participants who have a life expectancy of at least 3 months

Exclusion criteria

  • Participants with a history or complications of multiple cancers
  • Participants with a complication or history of severe hypersensitivity to any other antibody products
  • Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.

Treatment and study plan

ONO-4538

Drug

Specified dose on specified days

Other names: Nivolumab, Opdivo

Ipilimumab

Drug

Specified dose on specified days

Other names: BMS-734016, Yervoy

Oxaliplatin

Drug

Specified dose on specified days

Capecitabine

Drug

Specified dose on specified days

S-1

Drug

Specified dose on specified days

Other names: Tegafur-gimeracil-oteracil potassium

Primary outcomes

  1. Overall survival (OS)

    Time frame: up to 3 years

    (N/A)

Secondary outcomes

  1. Progression-free survival (PFS) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  2. Objective response rate (ORR) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  3. Best overall response (BOR) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  4. Duration of response (DOR) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  5. Disease control rate (DCR) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  6. Time to response (TTR) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  7. Maximum percent change in the sum diameters of the target lesions (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  8. Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)

    Time frame: up to 3 years

    (N/A)

  9. Adverse event

    Time frame: Up to 30 days after the last dose

    (N/A)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Dec 3, 2021
Registry last updated
Jun 25, 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.

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