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

Stopped early · Phase 2

Conditions studied: Malignant Melanoma

In brief

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

Key facts

Study ID

NCT01696045

Run by

Bristol-Myers Squibb

People needed

14

Starts

2012-11-12

Expected to finish

2016-07-31

Last updated by the study team

2017-08-29

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children'S Hospital — Phoenix, Arizona, United States
• Childrens Hospital Of La — Los Angeles, California, United States
• Children'S Hospital Of Orange County — Orange, California, United States
• Children'S Hospital Colorado — Aurora, Colorado, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• James Whitcomb Riley Hospital For Children — Indianapolis, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Of Pittsburgh Medical Center Cancer Center — Pittsburgh, Pennsylvania, United States
• St. Jude Children'S Research Hospital — Memphis, Tennessee, United States
• The University Of Texas Md Anderson Cancer Center — Houston, Texas, United States
• Primary Children'S Medical Center — Salt Lake City, Utah, United States
• University Of Utah — Salt Lake City, Utah, United States
• Local Institution — Ghent, Belgium
• Local Institution — Copenhagen, Denmark
• Local Institution — Lyon, France
• Local Institution — Marseille, France
• Local Institution — Nantes, France
• Local Institution — Villejuif, France
• Local Institution — Dortmund, Germany
• Local Institution — Erlangen, Germany
• Local Institution — Hamburg, Germany
• Local Institution — M?nster, Germany
• Local Institution — Münster, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.