The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Overall Survival (OS) Rate at 1 Year
Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.
Time frame: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.
Time frame: From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)
Disease Control Rate (DCR)
Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s).
Time frame: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Progression Free Survival
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Phoenix Children'S Hospital
Phoenix, Arizona, United States
Childrens Hospital Of La
Los Angeles, California, United States
Children'S Hospital Of Orange County
Orange, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania, United States
...and 22 more locations
Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment.
Time frame: From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)
Best Overall Response Rate (BORR)
Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s).
Time frame: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Overall Survival Time
Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date).
Time frame: From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)