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NCT01696045 Clinical 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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01696045
Other study ID # CA184-178
Secondary ID 2012-002249-39
Status Terminated
Phase Phase 2
First received September 26, 2012
Last updated August 24, 2016
Start date November 2012
Est. completion date July 2016

Study information
Verified date August 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Mexico: Federal Commission for Sanitary Risks ProtectionBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research EthicsItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Ipilimumab

Locations
Country Name City State
Belgium Local Institution Gent
Denmark Local Institution Copenhagen
France Local Institution Lyon
France Local Institution Marseille Cedex 5
France Local Institution Nantes Cedex 1
France Local Institution Villejuif Cedex
Germany Local Institution Dortmund
Germany Local Institution Erlangen
Germany Local Institution Hamburg
Germany Local Institution Munster
Mexico Local Institution Df Distrito Federal
Mexico Local Institution Leon, Guanajato Guanajuato
Mexico Local Institution Mexico D.F
Spain Local Institution Esplugues de Llobregat- Barcelona
United Kingdom Local Institution Bristol Avon
United Kingdom Local Institution Newcastle Northumberland
United Kingdom Local Institution Sutton Surrey
United States Children'S Hospital Colorado Aurora Colorado
United States Dana-Farber Cancer Institute Boston Massachusetts
United States The University Of Texas Md Anderson Cancer Center Houston Texas
United States James Whitcomb Riley Hospital For Children Indianapolis Indiana
United States Childrens Hospital Of La Los Angeles California
United States St. Jude Children'S Research Hospital Memphis Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Children'S Hospital Of Orange County Orange California
United States Phoenix Children'S Hospital Phoenix Arizona
United States University Of Pittsburgh Medical Center Cancer Center Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Primary Children'S Medical Center Salt Lake City Utah
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Mexico,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival Rate at 1-Year 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 Up to 1 year after last patient first treatment (LPFT) Yes
Primary Severe Immune-mediated Adverse Events (imARs) rate 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 Up to 1 year after LPFT Yes
Secondary Disease Control Rate (DCR) 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 Up to 1 year after LPFT No
Secondary Progression-Free Survival (PFS) 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 Up to 1 year after LPFT No
Secondary Best Overall Response Rate (BORR) 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 Up to 1 year after LPFT No
Secondary Overall Survival Up to 1 year after LPFT No
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