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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-04-30

Brief Summary

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The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Ipilimumab

Ipilimumab 10 mg/kg solution intravenously, 90 minute infusion, once every 3 weeks for 4 doses, then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Arm B: Best Supportive care (BSC)

BSC may include the continuation of the Fluoropyrimidine that was used during the lead-in chemotherapy, but no other systemic anti cancer therapy

Group Type OTHER

Best Supportive care (BSC)

Intervention Type OTHER

Interventions

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Ipilimumab

Intervention Type BIOLOGICAL

Best Supportive care (BSC)

Intervention Type OTHER

Other Intervention Names

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BMS-734016

Eligibility Criteria

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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 from 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No