Trial Name:
ICE - A Phase II trial of the addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for the first line treatment of Extensive Stage Small Cell Lung Cancer
Description:
ICE is a trial of the addition of Ipilimumab to Carboplatin and Etoposide chemotherapy for the first line treatment of Extensive Stage Small Cell Lung Cancer. It is a single stage, non-randomised, phase II trial.
Objectives:
- To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide.
- To assess the response to and toxicity of the combination of ipilimumab with carboplatin and etoposide chemotherapy.
- To examine whether ipilimumab stimulates a humoral immune response to onco-neuronal self-antigens The results from the above measurement of antibodies against onco-neuronal antigens will be used to focus the cellular biomarker analysis and identify targets to assess cellular responses:
- To measure the effect of ipilimumab on CD8+ T-cells directed against onco-neuronal antigens, presumed to be responsible for the desired cytotoxic activity against cancer cells.
- To evaluate the immune response to non-neuronal antigens in the presence of ipilimumab.
Design:
Single stage non-randomised phase II trial
Status:
Completed
Population:
Patients will be recruited so that 40 patients are treated with chemo-immunotherapy. The patients will be recruited from a minimum of 4 and maximum of 10 hospital sites.
Publications:
Outcome and biomarker analysis from a multi-centre phase 2 study of ipilimumab in combination with carboplatin and etoposide (ICE) as first line therapy for extensive stage small cell lung cancer
Contact Details:
All Trial enquiries should be addressed to ctu@soton.ac.uk