An efficacy study in gastric and gastroesophageal junction cancer comparing ipilimumab versus standard of care immediately following first line chemotherapy

• Conditions: ocally advanced (unresectable) or metastatic adenocarcinoma of the gastric and gastro-esophageal junction; MedDRA version: 14.1Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000853-22-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 152

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
? ECOG performance status of 0 or 1
? Measurable disease by modified WHO criteria (unless complete response for previous chemotherapy)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

?Known 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 clinical trial of medicinal product
• Study Design: Not specified