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 ClinicalTrials.gov)
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:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
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