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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01696045
First received: September 26, 2012
Last updated: July 5, 2017
Last verified: July 2017
  Purpose
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab

Condition Intervention Phase
Malignant Melanoma Biological: Ipilimumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.

  • Proportion 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 proportion 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) [ 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).


  • 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.

  • 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).


  • 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).


Enrollment: 14
Actual Study Start Date: November 12, 2012
Study Completion Date: July 7, 2016
Primary Completion Date: July 7, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab
Ipilimumab 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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696045

  Show 33 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01696045     History of Changes
Other Study ID Numbers: CA184-178
2012-002249-39 ( EudraCT Number )
Study First Received: September 26, 2012
Results First Received: July 5, 2017
Last Updated: July 5, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017