An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
Phase 2
- Conditions
- ocally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
- Registration Number
- JPRN-jRCT2080222028
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 114
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Progression free survival (PFS) per modified WHO criteria<br>- Overall survival (OS) <br>- Immune-related best overall response rate (irBORR)