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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction

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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