NCT05144854|Active Not RecruitingPhase 3DMCFDA Drug

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)

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)

Ono Pharmaceutical Co. Ltd ClinicalTrials.gov

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1 other identifier

ONO-4538-113

Study Type

interventional

Target

626

Locations

3 countries

Sites

Timeline

RegisteredDec 2021

StartedNov 2021

CompletionMay 2027

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

626

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline

12mo left

Started Nov 2021

Typical duration for phase_3 gastric-cancer

Geographic Reach

3 countries

57 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

Study Progress82%

Nov 2021May 2027

First Submitted

Initial submission to the registry

October 6, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed

28 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected

Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

4.5 years

First QC Date

October 6, 2021

Last Update Submit

September 1, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

Overall survival (OS)
up to 3 years

Secondary Outcomes (9)

Progression-free survival (PFS) (site investigator assessment)
up to 3 years
Objective response rate (ORR) (site investigator assessment)
up to 3 years
Best overall response (BOR) (site investigator assessment)
up to 3 years
Duration of response (DOR) (site investigator assessment)
up to 3 years
Disease control rate (DCR) (site investigator assessment)
up to 3 years
+4 more secondary outcomes

Study Arms (2)

ONO-4538 + ipilimumab + chemotherapy

EXPERIMENTAL

Drug: ONO-4538Drug: IpilimumabDrug: OxaliplatinDrug: CapecitabineDrug: S-1

Chemotherapy

ACTIVE COMPARATOR

Drug: OxaliplatinDrug: CapecitabineDrug: S-1