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
18 Years
N/A
Both
Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
Trial Information
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
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Immune-related progression free survival (irPFS) as per assessment of a blinded Independent Review Committee (IRC) according to immune related response criteria (irRC) guidelines
Outcome Description:
irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first
Outcome Time Frame:
91 irPFS events (Approximately 19 months following the first subject randomized)
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-162
NCT ID:
NCT01585987
Start Date:
July 2012
Completion Date:
June 2015
Related Keywords:
- Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Esophageal Diseases
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| NYU Clinical Cancer Center | New York, New York 10016 |
