CA184-367 study
Research type
Research Study
Full title
An observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European Expanded Access Programme in pretreated patients with advanced (unresectable or metastatic)melanoma.
IRAS ID
152610
Contact name
Nina Goyard
Contact email
Sponsor organisation
Bristol-Myers Squibb Research and Development
Duration of Study in the UK
0 years, 5 months, 16 days
Research summary
Advanced melanoma is an aggressive malignancy for which no widely effective therapy was available until the recent approval of ipilimumab and vemurafenib. Consequently, metastatic melanoma has been associated with very poor prognosis and remains a public health concern. Treatment of metastatic melanoma continues to represent a considerable unmet medical need based on the rising world-wide incidence of the disease and the unsatisfactory efficacy and significant toxicities of the currently available drugs.
To address the unmet medical need, Bristol-Myers Squibb (BMS) developed ipilimumab as a treatment for advanced melanoma.
The goal of this study is to understand the effectiveness and safety of ipilimumab in patients previously treated for advanced (unresectable or metastatic) melanoma in the context of the European Expanded Access Programme (EAP).
A total of 6,252 patients across Europe were included in the EAP, providing an opportunity to assess safety and efficacy outcomes of ipilimumab treatment in a large population in clinical practice outside of a clinical trial. Thus, the results of this study will contribute to a better understanding of effectiveness and safety profile of ipilimumab in a population that differs from population in the clinical trials, and therefore will provide additional valuable information to inform clinical practice.
REC name
North of Scotland Research Ethics Committee 1
REC reference
14/NS/1023
Date of REC Opinion
6 Aug 2014
REC opinion
Further Information Favourable Opinion