Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
- Conditions
- Malignant Melanoma
- Interventions
- Biological: Ipilimumab
- Registration Number
- NCT01696045
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 12 < 18 years of age
- Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
- Karnofsky Performance Status (KPS) or Lansky Score ≥ 50
- Primary Ocular Melanoma
- Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
- Symptomatic brain metastases
- History of autoimmune diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ipilimumab 3 mg/kg Ipilimumab Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. Ipilimumab 10 mg/kg Ipilimumab Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs) From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months) 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.
Overall Survival (OS) Rate at 1 Year 1 year following start of treatment (Assessed up to June 2016, approximately 38 months) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival Time From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months) 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).
Disease Control Rate (DCR) From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months) 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).Best Overall Response Rate (BORR) From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months) 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).Progression Free Survival From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months) 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.
Trial Locations
- Locations (15)
Phoenix Children'S Hospital
🇺🇸Phoenix, Arizona, United States
Childrens Hospital Of La
🇺🇸Los Angeles, California, United States
Children'S Hospital Colorado
🇺🇸Aurora, Colorado, United States
University Of Pittsburgh Medical Center Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
James Whitcomb Riley Hospital For Children
🇺🇸Indianapolis, Indiana, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
St. Jude Children'S Research Hospital
🇺🇸Memphis, Tennessee, United States
Primary Children'S Medical Center
🇺🇸Salt Lake City, Utah, United States
The University Of Texas Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
University Of Utah
🇺🇸Salt Lake City, Utah, United States
Local Institution
🇬🇧Sutton, Surrey, United Kingdom
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Children'S Hospital Of Orange County
🇺🇸Orange, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States