Ipilimumab dose comparison study in Metastatic Melanoma
Research type
Research Study
Full title
A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic Melanoma
IRAS ID
96775
Contact name
Paul Lorigan
Eudract number
2011-004029-28
Clinicaltrials.gov Identifier
Research summary
Melanoma is a serious type of skin cancer. If diagnosed at an early stage, before it has spread, some treatments may improve survival outcome. The outlook is not so good if it has spread before being treated. This is known as metastatic melanoma and depending on the stage, treatment options are chemotherapy, radiotherapy or immunotherapy such as Ipilimumab. Ipilimumab is a drug that stimulates the body??s immune system to react against the melanoma. It is approved for use in Europe for previously treated metastatic melanoma at a dose of 3mg/kg. The purpose of this study is to determine if patients with metastatic melanoma treated with ipilimumab 10mg/kg live longer than those treated with ipilimumab 3mg/.kg. The study will also look at how safe ipilimumab is and how well it works. The study will enrol 800 patients with previously treated or untreated unresectable Stage III or Stage IV melanoma, with about 45 patients taking part in the UK. Patients will be assigned 1: 1 to either 10 mg/kg or 3mg/kg treatment given via a 90 minute infusion every 3 weeks for a total of 4 infusions. Further treatment is allowed for patients who do not experience unacceptable side effects and who respond or have stable disease for 3 months or more. Patients who withdraw from treatment will be followed up. During the study, the spread or growth of cancer will be assessed by regular CT scans. Patients will undergo physical examinations and have blood samples taken at all study visits. Patients will also have urine taken, their weight and vital signs measured at some visits. The research is funded by Bristol Myers Squibb, and is being conducted globally with enrolment starting in March 2012, continuing until 2014.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0157
Date of REC Opinion
4 Apr 2012
REC opinion
Further Information Favourable Opinion