NCT00397345

TroVax Renal Immunotherapy Survival Trial

Randomised,Double-blind,Placebo-controlled,Parallel Group Study TroVax, Added to First-line Standard of Care, Prolongs Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 733 (actual)
• Sponsor: Oxford BioMedica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.

Detailed description

This is an international, randomised, double blind, placebo controlled, parallel group study to investigate whether a minimum of three doses of TroVax® added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic renal clear cell adenocarcinoma. The primary endpoint 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 permit comparison of the percentage of patients with progressive disease at 6 months as a secondary efficacy endpoint. Six months was selected based on review of published literature indicating that progressive disease was commonly observed by 26 weeks in patients with renal cancer. Endpoints such as tumour response by RECIST are considered of secondary importance to survival and will be determined by radiological examinations ordered at the discretion of the investigator based on the clinical status of the patient and will be based the interpretation of the patient's care-team (investigator and local radiologist). After signing the study informed consent form and meeting the baseline enrolment criteria patients will be assigned by the investigator (their physician) to one of the following defined first-line standard of care regimens based on what is best for the patient and consistent with local practice: 1. subcutaneous low dose IL-2 2. interferon-α (excluding pegylated IFNα) 3. sunitinib TroVax® is administered at a dose of 1E9TCID50/ml in 1ml 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.

Conditions

• Clear Cell Renal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Trovax	1ml IM injection 2-8 weeks apart.
BIOLOGICAL	Placebo	Placebo
BIOLOGICAL	Standard of care therapy	subcutaneous low dose IL-2, interferon-α or sunitinib

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-11-09
• Last updated: 2020-10-19

Locations

152 sites across 10 countries: United States, France, Germany, Israel, Poland, Romania, Russia, Spain, Ukraine, United Kingdom