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NCT Number: NCT06256328

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab 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 the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
  • Patients have not been treated with systemic chemotherapy as first-line therapy
  • Patients who can provide tumor tissue samples

Exclusion criteria

  • Patients unable to take oral medicines
  • Patients with HER2-positive
  • Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
  • Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
  • Patients with headache and/or nausea associated with brain metastasis

Treatment and study plan

ONO-4578

Drug

Specified dose, once daily

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

Nivolumab

Drug

Specified dose on specified days

Other names: Opdivo

Placebo

Drug

Specified dose, once daily

Primary outcomes

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

    Time frame: up to 2years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: up to 2years

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

    Time frame: up to 2years

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

    Time frame: up to 2years

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

    Time frame: up to 2years

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

    Time frame: up to 2years

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

    Time frame: up to 2years

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

    Time frame: up to 2years

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

    Time frame: up to 2years

  9. Adverse event (AE)

    Time frame: Up to 30 days after the last dose

    Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and 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
2024
Primary completion
2025
Study completion
2027
First posted
Feb 13, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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