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

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2012
End Date:	April 2015

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

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.

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Key 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)

Key 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

We found this trial at

sites

Mount Sinai Medical Center

Miami Beach, Florida 33140

from

Miami Beach, FL