Phase 2 Study of Ipilimumab in Children and Adolescents (12<18 years) with Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
Phase 1
- Conditions
- Malignant MelanomaMedDRA version: 17.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002249-39-BE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 12 < 18 years of age
- Previously Treated or Untreated, Unresectable - Stage III or Stage IV Malignant Melanoma
KPS or Lansky Score of = 50
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Primary Ocular Melanoma
- Prior therapy with CTLA-4 or PD-1 antagonist, or PD-L1 or CD137 agonists
- Symptomatic brain metastases
- History of autoimmune disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To estimate the survival rate at 1 year in adolescent patients (12 to < 18 years) with previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma.<br>- To assess safety and tolerability, specifically the frequency of severe (grade 3 - 5) immune-mediated adverse reactions of ipilimumab in adolescent patients (12 to < 18 years) at the 10 mg/kg dose level.<br>- To comply with the Pediatric Investigation Plan requirements for Ipilimumab;Secondary Objective: Using mWHO criteria:<br>-Disease Control Rate <br>-Progression Free Survival<br>-Best Overall Response Rate <br>-Overall Survival<br>;Primary end point(s): Overall Survival at 1 year and Frequency of Severe imARs (grade 3-5)<br>;Timepoint(s) of evaluation of this end point: Day 1 of FPFT to Day 365 from LPFT
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Using mWHO criteria:<br>-Disease Control Rate <br>-Progression Free Survival<br>-Best Overall Response Rate <br>-Overall Survival<br>;Timepoint(s) of evaluation of this end point: Analyses will be performed at the same time as the Primary Analysis