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