A184-178 Ipilimumab in children(aged 12- less than 18)with malignant m

• Research type

  Research Study

• Full title

  A phase 2 study of ipilimumab in children and adolescents (12 to less than 18 years) with previously treated or untreated, unresectable stage III or stage IV malignant melanoma

• IRAS ID

  114274

• Contact name

  Julia Chisholm

• Sponsor organisation

  Bristol-Myers Squibb Pharmaceuticals Limited

• Eudract number

  2012-002249-39

• ISRCTN Number

  N/A

• Research summary

  Malignant melanoma is a serious type of skin cancer. It is quite rare in children but is increasing in adolescents. Treatment options include surgery, chemotherapy, radiotherapy or immunotherapy. Ipilimumab is an immunotherapy drug that stimulates the body??s immune system to react against melanoma. It is approved for use in Europe for previously treated advanced (unresectable or metastatic) melanoma in adults at a dose of 3mg/kg, however ongoing studies suggest a dose of 10mg/kg may be more effective at treating the disease.Adolescents already have a mature immune system therefore the use of ipilimumab in this age group is expected to show a comparable safety and efficacy profile to that of adults. The purpose of this study is see whether ipilimumab is effective in adolescents aged 12-<18 years at a dose of 10mg/kg and to look at how long patients survive after treatment and how safe it is.This study will enrol approximately 40 adolescents with previously treated or untreated, unresectable Stage III or Stage IV melanoma, with about 3 patients taking part in the UK. Patients will receive ipilimumab at a dose of 10mg/kg via a 90 minute infusion every 3 weeks for a total of 4 infusions. Patients who respond to treatment or have stable disease and have no unacceptable side effects will continue to receive ipilimumab every 12 weeks until disease progression or until they achieve a complete response. Re-treatment may be given to patients whose disease subsequently progresses.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  13/EM/0012

• Date of REC Opinion

  21 Mar 2013

• REC opinion

  Further Information Favourable Opinion