Study Stopped
Slow accrual
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
2 other identifiers
interventional
14
8 countries
32
Brief Summary
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2012
Typical duration for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedStudy Start
First participant enrolled
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2016
CompletedResults Posted
Study results publicly available
August 1, 2017
CompletedAugust 29, 2017
July 1, 2017
3.7 years
September 26, 2012
July 5, 2017
July 31, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)
Secondary Outcomes (4)
Disease Control Rate (DCR)
From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Progression Free Survival
From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)
Best Overall Response Rate (BORR)
From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Overall Survival Time
From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)
Study Arms (2)
Ipilimumab 3 mg/kg
EXPERIMENTALIpilimumab (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
EXPERIMENTALIpilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Interventions
Eligibility Criteria
You may qualify if:
- \< 18 years of age
- Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
- Karnofsky Performance Status (KPS) or Lansky Score ≥ 50
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Phoenix Children'S Hospital
Phoenix, Arizona, 85016, United States
Childrens Hospital Of La
Los Angeles, California, 90027, United States
Children'S Hospital Of Orange County
Orange, California, 92868, United States
Children'S Hospital Colorado
Aurora, Colorado, 80045, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, 46202, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University Of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
St. Jude Children'S Research Hospital
Memphis, Tennessee, 38105, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
Primary Children'S Medical Center
Salt Lake City, Utah, 84113, United States
University Of Utah
Salt Lake City, Utah, 84113, United States
Local Institution
Ghent, 9000, Belgium
Local Institution
Copenhagen, 2100, Denmark
Local Institution
Lyon, 69008, France
Local Institution
Marseille, 13385, France
Local Institution
Nantes, 44093, France
Local Institution
Villejuif, 94805, France
Local Institution
Dortmund, 44137, Germany
Local Institution
Erlangen, 91054, Germany
Local Institution
Hamburg, 20246, Germany
Local Institution
M?nster, 48149, Germany
Local Institution
Münster, 48149, Germany
Local Institution
México, D.F, 02990, Mexico
Local Institution
Leon, Guanajato, Guanajuato, 37000, Mexico
Local Institution
Df, Mexico City, 06720, Mexico
Local Institution
Esplugues de Llobregat- Barcelona, 08950, Spain
Local Institution
Bristol, Avon, BS2 8BJ, United Kingdom
Local Institution
Newcastle, Northumberland, NE1 4LP, United Kingdom
Local Institution
Sutton, Surrey, SM2 5PT, United Kingdom
Related Publications (1)
Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.
PMID: 29100190DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2012
First Posted
September 28, 2012
Study Start
November 12, 2012
Primary Completion
July 31, 2016
Study Completion
July 31, 2016
Last Updated
August 29, 2017
Results First Posted
August 1, 2017
Record last verified: 2017-07