• About Trist
  • What is TroVax
  • Trial objectives
  • Trial locations
• For Patients
  • Trial information
  • Renal cancer
• For Clinicians
  • Trial design
  • Trial objectives
  • Patient population
• Other Trials
  • QUASAR V
  • FLAMENCO
  • Phase II HPRC
• Contact Us

TRIST stands for TroVax^® Renal Immunotherapy Survival Trial. This Phase III trial has completed recruitment of 733 patients with a specific type of kidney cancer called clear cell renal carcinoma, which has advanced locally or spread around the body. Patients who had not received any previous treatment for their condition were considered for the trial, so long as their clinician was practising at a registered centre and the patients fulfilled a number of specific criteria. These criteria were set both for safety reasons and to make sure that we can evaluate the results of the study in a meaningful way.

Once a volunteer recovered from their surgery to remove the original, or primary, tumour, their clinician decided which type of first-line treatment they would receive. This treatment was either interleukin-2, interferon-alpha or sunitinib. The patient was then assigned either to the control group, where they were given a placebo, or to the study group, where they were given TroVax.

Before any treatment was given, patients involved in the trial had to undergo a CT scan, to measure the size of any residual tumours at the start of the study.

TroVax is administered as an injection into the muscle in a patient’s arm. Over the course of the trial patients can be given up to 13 injections. These are given between two to eight weeks apart, and at each visit to the hospital the patients will be monitored for any adverse reaction to the treatment.

Providing their disease remains stable patients continue to receive injections of TroVax over 26 weeks. At this time they undergo a further CT scan, and the results of this will be compared with the original scan. The continuing progress of the disease will be monitored, for the rest of a volunteer’s life, even once the TroVax treatment is stopped.

If at any time any volunteer wants to pull out of the trial they can discuss this with their clinician.

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.

Patient Information Leaflet

Website by College Hill - Life Sciences