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Primary efficacy objective

To assess whether the addition of TroVax to first line standard of care, will prolong survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma when compared to placebo. This will be assessed in the Intent to Treat, (ITT), population. The amendments to the study agreed with the FDA in October 2008 are designed to explore whether patient outcome is dependent on the number of doses, background standard of care and patients' prognostic factors.

Primary safety objective

To assess whether the addition of TroVax to first line standard of care alters the profile of serious and non-serious adverse events, when compared to placebo, in patients with locally advanced or metastatic clear cell renal adenocarcinoma. This will be assessed in ITT population.

Secondary efficacy objectives

To compare the proportion of patients with progression free survival at 26 weeks in the TroVax versus placebo arms. This will be assessed in the ITT population.

To compare the tumour response rates, time to response and duration of response between patients treated with TroVax versus placebo. This will be analysed in the ITT population.

To assess whether the addition of a minimum of three doses of TroVax to first line standard of care will prolong survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma when compared to placebo.

This will be an exploratory analysis in the Modified Intent to Treat population (MITT). To assess whether TroVax has an impact on the quality of life as measured by QLQ30 and EuroQOL questionnaires when compared to placebo. This will be analysed in the ITT population.

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