Ipilimumab compared to placebo in stage III melanoma after surgery
Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group
Bristol-Myers Squibb International Corporation
Adjuvant Ipilimumab versusplacebo for Stage III Melanoma. Malignant melanoma is the most serious type ofskin cancer. Stage III melanoma (where there has been spread to the lymphnodes) is an aggressive disease with a 46% 5-year survival rate. Due to thelimited efficacy (how well the treatment works) together with frequent side effectsexperienced with existing treatment (such as interferon), there is a need fornew drugs for patients who have had their melanoma cells removed during anoperation (surgically resected melanoma) but who remain at high risk of theirmelanoma coming back (recurrence). Immunotherapies may improve the survivaloutcome for these patients. The purpose of this study is to determine thesafety and efficacy of post-surgery treatment with the monoclonal antibodyipilimumab, to see whether treatment improves recurrence-free survival, overallsurvival and distant metastases-free survival, compared to placebo (dummytreatment). This will be done in patients who are currently free of disease butremain at high risk of melanoma recurrence. The study will enrol 950 patientswith Stage III melanoma, assigned 1:1 to either ipilimumab 10 mg/kg treatmentor placebo. Treatment will start after surgical removal of the primary melanomaand additional sites of disease (nodes). Ipilimumab is given via a 90 minuteinfusion every 3 weeks for a total of 4 infusions, then every 12 weeks for amaximum of 3 years or until recurrence, unacceptable toxicity or earlywithdrawal from the study. During the study, patients will undergo physicalexaminations and have blood samples taken at all study visits. Patients willhave urine taken, weight and vital signs measured at some visits, and willundergo one electrocardiogram (ECG) and 2 eye (opthalmological) examinations.Patients will undego CT or MRI scanning approximately every 3 months12 weeks.The study is funded by Bristol-Myers Squibb, and is being conducted in Europe,North America, Canada and Australia. Enrolment starts in North America insummer 2008 and will continue until late 2010. The choice of placebo ascomparator arm is possible since interpheron-alpha improves only relapse freesurvival and not overall survival, and when administered as last choice therapyin advanced disease provides a similar benefit as compared to adjuvant.
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
Date of REC Opinion
6 Oct 2008
Further Information Favourable Opinion