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)

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06256328
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • 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
  • Nivolumab — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose, once daily

Study Details

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).

Key Dates

Start date
Jan 10, 2024
Status verified
Mar 2026
Primary completion
Oct 9, 2025
Completion
Jul 31, 2027

Study Design

Enrollment
226 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-4578+Nivolumab+chemotherapy
  • Placebo Comparator: placebo+Nivolumab+chemotherapy

Primary Outcome Measure

Progression-free survival (PFS) (site investigator assessment) [ Time Frame: up to 2years ]

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