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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 CenterNew York, New York  10021
Mount Sinai Medical CenterMiami Beach, Florida  33140
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
NYU Clinical Cancer CenterNew York, New York  10016