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| For Clinicians / Trial Design |
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TRIST is a double-blind placebo-controlled randomised study for patients with locally advanced or metastatic clear cell kidney cancer. The primary endpoint of this study is survival. The study is designed to be pragmatic, limiting additional study-related investigations to a minimum. Protocol mandated scans and X-rays are limited to two time points (baseline and week 26) to allow a comparison of the percentage of patients with progressive disease at six months as a secondary efficacy endpoint.
Study enrolment commenced at each centre once ethics and regulatory approval had been obtained from the relevant authorities. After signing the study informed consent form and meeting the baseline enrolment criteria patients were assigned by the investigator (their physician) to one of the following defined first-line standard of care regimens based on what was best for the patient and consistent with local practice:
Once the standard of care therapy has been decided the investigator can telephone the Interactive Voice Recognition Service (IVRS). Randomisation to TroVax or placebo will be stratified based on the standard of care chosen by the investigator, study prognostic indicators (Motzer score) and geography. TroVax or placebo is administered at a single dose level in 1 ml by injection into the deltoid muscle of the upper arm at regular intervals up to 8 weeks apart, up to a maximum of 13 doses. In July 2008, following its fourth interim review, the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study recommended that the trial should continue but that further vaccinations be discontinued. The DSMB advised that TroVax administered according to the protocol will not meet the predefined primary efficacy endpoint, but there is important scientific merit and more to be learned by additional follow up of all patients.
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