Cancer Immunology, Immunotherapy

, Volume 62, Issue 9, pp 1511–1520

Vaccination of castration-resistant prostate cancer patients with TroVax (MVA–5T4) in combination with docetaxel: a randomized phase II trial


    • Oxford BioMedica (UK) Ltd., The Medawar CentreOxford Science Park
  • Franklin Chu
    • San Bernardino Urology
  • Nashat Gabrail
    • Gabrail Cancer Center Research
  • Sandy Srinivas
    • Stanford University Medical Center
  • Daniel Blount
    • Oxford BioMedica (UK) Ltd., The Medawar CentreOxford Science Park
  • Anna Ferrari
    • New York University Cancer Institute
Original Article

DOI: 10.1007/s00262-013-1457-z

Cite this article as:
Harrop, R., Chu, F., Gabrail, N. et al. Cancer Immunol Immunother (2013) 62: 1511. doi:10.1007/s00262-013-1457-z


The attenuated vaccinia virus, modified vaccinia Ankara, has been engineered to deliver the tumor antigen 5T4 (TroVax®). Here, we report results from a randomized open-label phase II trial in castration-resistant prostate cancer patients in which TroVax was administered in combination with docetaxel and compared against docetaxel alone. The aim was to recruit 80 patients (40 per arm), but the study was terminated early due to recruitment challenges. Therefore, this paper reports the comparative safety and immunological and clinical efficacy in 25 patients, 12 of whom were treated with TroVax plus docetaxel and 13 with docetaxel alone. 5T4-specific immune responses were monitored throughout the study. Clinical responses were assessed by measuring changes in tumor burden by CT and bone scan and by quantifying PSA concentrations. TroVax was well tolerated in all patients. Of 10 immunologically evaluable patients, 6 mounted 5T4-specific antibody responses. Patients treated with TroVax plus docetaxel showed a greater median progression-free survival of 9.67 months compared with 5.10 months for patients on the docetaxel alone arm (P = 0.097; HR = 0.31; 95 % CI 0.08–1.24). Importantly, a pre-treatment biomarker previously demonstrated to predict 5T4 immune response and treatment benefit showed a strong association with 5T4 antibody response and a statistically significant association with progression-free survival in patients treated with TroVax plus docetaxel, but not docetaxel alone.


Castration-resistant prostate cancerCancer vaccine5T4 tumor antigenBiomarkerDocetaxel

Copyright information

© Springer-Verlag Berlin Heidelberg 2013