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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
143
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
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.
Time frame: Randomization up to 91 irPFS events (Approximately 19 months )
Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
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).
Time frame: Randomization up to 91 irPFS events (Approximately 19 months )
Overall Survival (OS) at Primary Endpoint
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.
Time frame: Randomization up to 91 irPFS events (Approximately 19 months)
Overall Survival (OS) at Study Completion
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.
Time frame: Randomization up to end of study, April 2015 (Approximately 28 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mount Sinai Medical Center
Miami Beach, Florida, United States
Nyu Clinical Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Local Institution
Montpellier, France
Local Institution
Nice, France
Local Institution
Rennes, France
Local Institution
Toulouse, France
Local Institution
Mainz, Germany
Local Institution
Hong Kong, Hong Kong
...and 26 more locations
Percentage of Participants With Immune-Related Best Overall Response (irBOR)
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).
Time frame: Randomization up to 91 irPFS events (Approximately 19 months)