Cancer Immunology, Immunotherapy

, Volume 66, Issue 7, pp 891–901

Phase I/IIa clinical trial of a novel hTERT peptide vaccine in men with metastatic hormone-naive prostate cancer

  • Wolfgang Lilleby
  • Gustav Gaudernack
  • Paal F. Brunsvig
  • Ljiljana Vlatkovic
  • Melanie Schulz
  • Kate Mills
  • Knut Håkon Hole
  • Else Marit Inderberg
Original Article


In newly diagnosed metastatic hormone-naive prostate cancer (mPC), telomerase-based immunotherapy with the novel hTERT peptide vaccine UV1 can induce immune responses with potential clinical benefit. This phase I dose escalation study of UV1 evaluated safety, immune response, effects on prostate-specific antigen (PSA) levels, and preliminary clinical outcome. Twenty-two patients with newly diagnosed metastatic hormone-naïve PC (mPC) were enrolled; all had started androgen deprivation therapy and had no visceral metastases. Bone metastases were present in 17 (77%) patients and 16 (73%) patients had affected lymph nodes. Three dose levels of UV1 were given as intradermal injections combined with GM-CSF (Leukine®). Twenty-one patients in the intention-to-treat population (95%) received conformal radiotherapy. Adverse events reported were predominantly grade 1, most frequently injection site pruritus (86.4%). Serious adverse events considered possibly related to UV1 and/or GM-CSF included anaphylactic reaction in two patients and thrombocytopenia in one patient. Immune responses against UV1 peptides were confirmed in 18/21 evaluable patients (85.7%), PSA declined to <0.5 ng/mL in 14 (64%) patients and in ten patients (45%) no evidence of persisting tumour was seen on MRI in the prostatic gland. At the end of the nine-month reporting period for the study, 17 patients had clinically stable disease. Treatment with UV1 and GM-CSF gave few adverse events and induced specific immune responses in a large proportion of patients unselected for HLA type. The intermediate dose of 0.3 mg UV1 resulted in the highest proportion of, and most rapid UV1-specific immune responses with an acceptable safety profile. These results warrant further clinical studies in mPC.


Prostate cancer hTERT Cancer vaccine Immune response 



Androgen deprivation therapy


Good clinical practice


Human telomerase reverse transcriptase


Prostate cancer clinical trials working group


Progressive disease


Prostate-specific antigen


Stable disease


Stimulation index

Supplementary material

262_2017_1994_MOESM1_ESM.pdf (148 kb)
Supplementary material 1 (PDF 147 KB)

Copyright information

© Springer-Verlag Berlin Heidelberg 2017

Authors and Affiliations

  1. 1.Department of Oncology and RadiotherapyOslo University Hospital-RadiumhospitaletOsloNorway
  2. 2.Section for Cancer ImmunologyOslo University Hospital-RadiumhospitaletOsloNorway
  3. 3.Department for Clinical Cancer ResearchOslo University Hospital-RadiumhospitaletOsloNorway
  4. 4.Department of PathologyOslo University Hospital-RadiumhospitaletOsloNorway
  5. 5.Department of RadiologyOslo University Hospital-RadiumhospitaletOsloNorway
  6. 6.Department of Cellular TherapyOslo University Hospital-RadiumhospitaletOsloNorway
  7. 7.Ultimovacs ASOsloNorway

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