Trial · 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)
NCT05144854, Phase 3, Active not recruiting, Ono Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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). Trials, record NCT05144854. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05144854
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT05144854
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 626 participants, actual
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Conditions
- Gastric Cancer
- Interventions
- ONO-4538, Ipilimumab, Oxaliplatin, Capecitabine, S-1
- First posted
- 2021-12-03
- Last updated
- 2026-06-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | up to 3 years | (N/A) |
| Secondary | Progression-free survival (PFS) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Objective response rate (ORR) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Best overall response (BOR) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Duration of response (DOR) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Disease control rate (DCR) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Time to response (TTR) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Maximum percent change in the sum diameters of the target lesions (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) | up to 3 years | (N/A) |
| Secondary | Adverse event | Up to 30 days after the last dose | (N/A) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05144854
GET https://conductscience.org/api/trials/v1/NCT05144854/registered