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: 15.0Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000853-22-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-03
• Last Update Posted: 18 January 2016

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: 0
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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of the study is to compare the efficacy of ipilimumab and standard of care immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.;Secondary Objective: • progression free survival (PFS) per modified WHO criteria, • Overall survival (OS), • immune-related best overall response rate (irBORR);Primary end point(s): Immune-related progression free survival (irPFS) as per assessment of a blinded Independent Review Committee (IRC) according to immune related response criteria (irRC) guidelines.;Timepoint(s) of evaluation of this end point: 91 irPFS events

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • progression free survival (PFS) per modified WHO criteria, • Overall survival (OS), • immune-related best overall response rate (irBORR);Timepoint(s) of evaluation of this end point: 91 irPFS events