Phase I/II Trial of RNActive derived vaccine in Prostate Cancer

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients with Metastatic Castrate-refractory Prostate Cancer

• IRAS ID

  103470

• Contact name

  Isabel Syndikus

• Sponsor organisation

  CureVac GmbH

• Eudract number

  2011-006314-14

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Prostate cancer is now the most common cancer in men in the UK (not counting non melanoma skin cancer)and about half of all men diagnosed develop prostate cancer (PCA) with metastatic ?? meaning spreading from one organ to another and castrate??refractory ?? meaning developing progressive disease despite continuing hormone therapy. Since no curative treatment options are available for patients with metastatic castrate refractory PCA, new well tolerated treatments that prolong survival without adding considerable side effects are needed. This research study is being conducted by CureVac GmbH, in order to test a new study drug named 'CV9104' in this setting. CV9104 is a RNActive based vaccine of 6 different components which induces a immune response of the patients to prostate cancer cells. The aim of this treatment is to improve survival and cancer control without significant side effects beyond and above what is achievable with current hormonal or chemotherapy agents. In this randomised placebo controlled trial, patients receive CV9104 or placebo (study drug) in a 2:1 ratio in favour of the CV9104 arm. Treatment with the study drug will be administered on Day 1 of weeks 1, 2, 3, 5, 7, 9, 12, 15, 18 and 24, then every 6 weeks for up to 12 months following the first vaccination and then every 3 months until disease one of the criteria for the study treatment discontinuation is met.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  12/YH/0467

• Date of REC Opinion

  20 Nov 2012

• REC opinion

  Further Information Favourable Opinion