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
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Primary Completion Date :||July 2014|
|Study Completion Date :||April 2015|
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)
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)|
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585987
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|