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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01585987
First received: April 25, 2012
Last updated: April 15, 2016
Last verified: April 2016

April 25, 2012
April 15, 2016
July 2012
July 2014   (final data collection date for primary 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 [ 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.
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: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ 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
Complete list of historical versions of study NCT01585987 on ClinicalTrials.gov Archive Site
  • 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).
  • Progression free survival (PFS) per modified WHO criteria [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    PFS per modified WHO (mWHO) is defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurs first
  • Overall Survival (OS) [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    OS is defined as the time from the date of randomization until the date of death. For those subjects who have not died, OS will be censored on the last date the subjects was known to be alive
  • Immune-related best overall response rate (irBORR) [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    IrBORR is defined as the number of subjects 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 response evaluable subjects
Not Provided
Not Provided
 
An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
  • Biological: Ipilimumab
    Other Name: BMS-734016
  • Other: Best Supportive care (BSC)
  • 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)
    Intervention: Biological: Ipilimumab
  • 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
    Intervention: Other: Best Supportive care (BSC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
April 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan
 
NCT01585987
CA184-162, 2011-000853-22
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP