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

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ClinicalTrials.gov Identifier: NCT01585987
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : November 18, 2015
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 25, 2012
First Posted Date  ICMJE April 26, 2012
Results First Submitted Date  ICMJE July 15, 2015
Results First Posted Date  ICMJE November 18, 2015
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
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 ) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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) ]
irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first
Change History Complete list of historical versions of study NCT01585987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
  • Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months ) ]
    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) ]
    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) ]
    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) ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
  • Progression free survival (PFS) per modified WHO criteria [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ]
    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) ]
    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) ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
Intervention  ICMJE
  • Biological: Ipilimumab
    Other Name: BMS-734016
  • Other: Best Supportive care (BSC)
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2015)
143
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2012)
114
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01585987
Other Study ID Numbers  ICMJE CA184-162
2011-000853-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2016

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