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 is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01696045
First received: September 26, 2012
Last updated: October 13, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Rate at 1-Year [ Time Frame: Up to 1 year after last patient first treatment (LPFT) ] [ Designated as safety issue: Yes ]
    Overall Survival Rate at 1-Year is defined as the probability that a subject is alive at one year following start of treatment. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment

  • Severe Immune-mediated Adverse Events (imARs) rate [ Time Frame: Up to 1 year after LPFT ] [ Designated as safety issue: Yes ]
    Severe imARs rate is defined as the total number of treated subjects who were categorized as having a grade 3 or worse imAR divided by the total number of treated subjects. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment


Secondary Outcome Measures:
  • Disease Control Rate (DCR) [ Time Frame: Up to 1 year after LPFT ] [ Designated as safety issue: No ]
    DCR is defined as the total number of treated subjects with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), divided by the total number of treated subjects. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment

  • Progression-Free Survival (PFS) [ Time Frame: Up to 1 year after LPFT ] [ Designated as safety issue: No ]
    PFS is defined for each subject as the time from start of ipilimumab treatment to progression or death, whichever occurs first. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment

  • Best Overall Response Rate (BORR) [ Time Frame: Up to 1 year after LPFT ] [ Designated as safety issue: No ]
    BORR is defined as the total number of treated subjects with a best overall response of CR or PR, divided by the total number of treated subjects. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment

  • Overall Survival [ Time Frame: Up to 1 year after LPFT ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab
Ipilimumab 3 mg/Kg solution by Intravenous (IV) once every 3 weeks for 4 doses, then every 12 weeks until progression of disease or unacceptable toxicity
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS- 734016

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 32 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01696045     History of Changes
Other Study ID Numbers: CA184-178, 2012-002249-39
Study First Received: September 26, 2012
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Federal Commission for Sanitary Risks Protection
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 22, 2014