Clinical trial NCT01696045: 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
Official title: Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-09-28
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Survival (OS) Rate at 1 Year
timeFrame: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
measure: Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
timeFrame: From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
measure: Progression Free Survival
timeFrame: From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)
measure: Best Overall Response Rate (BORR)
timeFrame: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
measure: Overall Survival Time
timeFrame: From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children'S Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Childrens Hospital Of La
state: California
city: Orange
country: United States
facility: Children'S Hospital Of Orange County
state: California
city: Aurora
country: United States
facility: Children'S Hospital Colorado
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital For Children
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: University Of Pittsburgh Medical Center Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children'S Research Hospital
state: Tennessee
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children'S Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University Of Utah
state: Utah
city: Gent
country: Belgium
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Lyon
country: France
facility: Local Institution
city: Marseille Cedex 5
country: France
facility: Local Institution
city: Nantes Cedex 1
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Dortmund
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: M?nster
country: Germany
facility: Local Institution
city: Munster
country: Germany
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: D.F
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Leon, Guanajato
country: Mexico
facility: Local Institution
state: Guanajuato
city: Esplugues de Llobregat- Barcelona
country: Spain
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
state: Avon
city: Newcastle
country: United Kingdom
facility: Local Institution
state: Northumberland
city: Sutton
country: United Kingdom
facility: Local Institution
state: Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.