An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy

A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222028

Enrollment

114

Registered

2013-02-20

Start date

2013-02-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction

Interventions

investigational material(s) Generic name etc : Ipilimumab (BMS-734016) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction - Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease by modified WHO criteria (unless complete response for previous chemotherapy)

Exclusion criteria

Exclusion criteria: - Known Human Epidermal growth factor Receptor2 (HER2) positive status - Radiological evidence of brain metastases - History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment - Inadequate hematologic, renal and hepatic function

Design outcomes

Primary

Measure	Time frame
Immune-related progression free survival (irPFS) as per assessment of a blinded Independent Review Committee (IRC) according to immune related response criteria (irRC) guidelines	—

Secondary

Measure	Time frame
- Progression free survival (PFS) per modified WHO criteria - Overall survival (OS) - Immune-related best overall response rate (irBORR)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026