The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues or efficacy issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis and is comprised of leading clinicians and biostatisticians with relevant expertise in the treatment of renal cancer and the conduct of clinical trials.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies are interleukin-2, interferon-alpha or Sutent® (sunitinib). The protocol stratifies treatment between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced.
The trial started in November 2006. To date, more than 500 patients have been randomised of a target enrolment of approximately 700 patients. Over 100 sites in the USA, European Union and Eastern Europe are recruiting patients. The primary endpoint for the trial is overall survival in the TroVax-treated group versus the placebo group. Secondary endpoints include progression-free survival at 26 weeks, tumour response rates and quality of life scores. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA.
Dr Mike McDonald, Oxford BioMedica’s Chief Medical Officer, commented on the DSMB recommendation: “This interim analysis by the DSMB is an important step in the progress of the TRIST study. It is the first analysis that compares the safety and efficacy of the TroVax and placebo arms of the study. We are delighted by the positive recommendation. We remain on track to complete patient enrolment during Q1 2008 and we anticipate final results in 2009.”
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