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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

Primary Purpose

Malignant Melanoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children'S Hospital
  • Childrens Hospital Of La
  • Children'S Hospital Of Orange County
  • Children'S Hospital Colorado
  • H. Lee Moffitt Cancer Center & Research Institute
  • James Whitcomb Riley Hospital For Children
  • Dana-Farber Cancer Institute
  • Mayo Clinic
  • Memorial Sloan Kettering Cancer Center
  • University Of Pittsburgh Medical Center Cancer Center
  • St. Jude Children'S Research Hospital
  • The University Of Texas Md Anderson Cancer Center
  • Primary Children'S Medical Center
  • University Of Utah
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ipilimumab 3 mg/kg

Ipilimumab 10 mg/kg

Arm Description

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) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
Progression Free Survival
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.
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).
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).

Full Information

First Posted
September 26, 2012
Last Updated
July 31, 2017
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01696045
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
November 12, 2012 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab 3 mg/kg
Arm Type
Experimental
Arm Description
Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Arm Title
Ipilimumab 10 mg/kg
Arm Type
Experimental
Arm Description
Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS- 734016
Primary Outcome Measure Information:
Title
Overall Survival (OS) Rate at 1 Year
Description
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)
Title
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
Description
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)
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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)
Title
Progression Free Survival
Description
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)
Title
Best Overall Response Rate (BORR)
Description
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)
Title
Overall Survival Time
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children'S Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Childrens Hospital Of La
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children'S Hospital Of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children'S Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
James Whitcomb Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Of Pittsburgh Medical Center Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
St. Jude Children'S Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
The University Of Texas Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children'S Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
University Of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Local Institution
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
M?nster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Mexico
State/Province
D.F
ZIP/Postal Code
02990
Country
Mexico
Facility Name
Local Institution
City
Df
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution
City
Leon, Guanajato
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution
City
Esplugues de Llobregat- Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Local Institution
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle
State/Province
Northumberland
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Local Institution
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29100190
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.
Results Reference
derived
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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