BRaVac: Phase II Study of RV001V in men with localized prostate cancer

• Research type

  Research Study

• Full title

  A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men with Biochemical Failure following Curatively Intended Therapy For Localized Prostate Cancer

• IRAS ID

  269071

• Contact name

  Simon CRABB

• Contact email

  S.J.Crabb@southampton.ac.uk

• Sponsor organisation

  RhoVac ApS

• Eudract number

  2019-000951-14

• Duration of Study in the UK

  3 years, 4 months, 6 days

• Research summary

  This study will evaluate the efficacy, safety and tolerability of RV001V, an investigational cancer vaccine against metastases from solid tumors.
  This vaccine will be evaluated in a phase 2,randomized, double blind,placebo controlled study in adult male with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence after radical prostatectomy or definitive radiotherapy without distant metastasis and locoregional recurrence.
  The study will randomize approximately 180 patients to either RV001V or placebo treatment in a 1:1 manner. The objective of this Phase II study is to investigate whether a vaccination regimen with multiple subcutaneous (SC) administrations of RV001 Vaccine 0.1 mg/mL can reduce prostate-specific antigen (PSA) progression compared to the control group.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  20/SC/0003

• Date of REC Opinion

  25 Feb 2020

• REC opinion

  Further Information Favourable Opinion