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)

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT05144854
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • ONO-4538 — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Capecitabine — DRUG
    Specified dose on specified days
  • S-1 — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

First listed
Dec 3, 2021
Start date
Nov 5, 2021
Status verified
Jun 2026
Primary completion
Oct 20, 2025
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: ONO-4538 + ipilimumab + chemotherapy
  • Active Comparator: Chemotherapy

Primary Outcome Measure

Overall survival (OS) [ Time Frame: up to 3 years ]

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