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

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Solid Tumors
NCT ID: NCT01696045 (View complete trial on
DFCI Protocol ID: 12-390


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


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Carlos Rodriguez-Galindo, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,

Eligibility Criteria

Inclusion Criteria: - 12 to < 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
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