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

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: April 25, 2012
Last updated: April 15, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
Biological: Ipilimumab
Other: Best Supportive care (BSC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months ) ] [ Designated as safety issue: No ]
    irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.

Secondary Outcome Measures:
  • Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months ) ] [ Designated as safety issue: No ]
    PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).

  • Overall Survival (OS) at Primary Endpoint [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.

  • Overall Survival (OS) at Study Completion [ Time Frame: Randomization up to end of study, April 2015 (Approximately 28 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.

  • Percentage of Participants With Immune-Related Best Overall Response (irBOR) [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months) ] [ Designated as safety issue: No ]
    IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).

Enrollment: 143
Study Start Date: July 2012
Study Completion Date: April 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Biological: Ipilimumab
Other Name: BMS-734016
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
Other: Best Supportive care (BSC)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01585987

  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01585987     History of Changes
Other Study ID Numbers: CA184-162  2011-000853-22 
Study First Received: April 25, 2012
Results First Received: July 15, 2015
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Poland: National Institute of Medicines
Hong Kong: Department of Health
Italy: Ministry of Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Korea: Korea Food and Drug Administration (KFDA)
United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial processed this record on May 23, 2016