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

July 31, 2017 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Local Institution
  • Denmark
      • Copenhagen, Denmark, 2100
        • Local Institution
  • France
      • Lyon, France, 69008
        • Local Institution
      • Marseille Cedex 5, France, 13385
        • Local Institution
      • Nantes Cedex 1, France, 44093
        • Local Institution
      • Villejuif Cedex, France, 94805
        • Local Institution
  • Germany
      • Dortmund, Germany, 44137
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
      • M?nster, Germany, 48149
        • Local Institution
      • Munster, Germany, 48149
        • Local Institution
  • Mexico
    • D.F
      • Mexico, D.F, Mexico, 02990
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Mexico, 06720
        • Local Institution
    • Guanajuato
      • Leon, Guanajato, Guanajuato, Mexico, 37000
        • Local Institution
  • Spain
      • Esplugues de Llobregat- Barcelona, Spain, 08950
        • Local Institution
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8BJ
        • Local Institution
    • Northumberland
      • Newcastle, Northumberland, United Kingdom, NE1 4LP
        • Local Institution
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Childrens Hospital of LA
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • James Whitcomb Riley Hospital For Children
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center
      • Salt Lake City, Utah, United States, 84113
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ipilimumab 3 mg/kg
Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS- 734016
Experimental: Ipilimumab 10 mg/kg
Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS- 734016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Rate at 1 Year
Time Frame: 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.
1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
Time Frame: 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.
From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 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).
From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Progression Free Survival
Time Frame: 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.
From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)
Best Overall Response Rate (BORR)
Time Frame: 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).
From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Overall Survival Time
Time Frame: 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).
From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2012

Primary Completion (Actual)

July 31, 2016

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-178
  • 2012-002249-39 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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