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

• 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: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: April 25, 2012
• First Posted Date: April 26, 2012
• Results First Submitted Date: July 15, 2015
• Results First Posted Date: November 18, 2015
• Last Update Posted Date: May 17, 2016
• Study Start Date: July 2012
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction

Intervention

• Biological: Ipilimumab
  Other Name: BMS-734016
• Other: Best Supportive care (BSC)

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2015): 143
• Original Estimated Enrollment (submitted: April 25, 2012): 114
• Actual Study Completion Date: April 2015
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Singapore, Spain, Taiwan, United States

Administrative Information

• NCT Number: NCT01585987
• Other Study ID Numbers: CA184-162; 2011-000853-22 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: April 2016