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Cancer Immunol Immunother. 2017 Jul;66(7):891-901. doi: 10.1007/s00262-017-1994-y. Epub 2017 Apr 8.

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

Author information

1
Department of Oncology and Radiotherapy, Oslo University Hospital-Radiumhospitalet, PO Box 4953, Nydalen, 0424, Oslo, Norway. Wolfgang.lilleby@ous-hf.no.
2
Section for Cancer Immunology, Oslo University Hospital-Radiumhospitalet, Oslo, Norway.
3
Ultimovacs AS, Oslo, Norway.
4
Department for Clinical Cancer Research, Oslo University Hospital-Radiumhospitalet, Oslo, Norway.
5
Department of Pathology, Oslo University Hospital-Radiumhospitalet, Oslo, Norway.
6
Department of Oncology and Radiotherapy, Oslo University Hospital-Radiumhospitalet, PO Box 4953, Nydalen, 0424, Oslo, Norway.
7
Department of Radiology, Oslo University Hospital-Radiumhospitalet, Oslo, Norway.
8
Department of Cellular Therapy, Oslo University Hospital-Radiumhospitalet, Oslo, Norway.

Abstract

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.

KEYWORDS:

Cancer vaccine; Immune response; Prostate cancer; hTERT

PMID:
28391357
DOI:
10.1007/s00262-017-1994-y
[Indexed for MEDLINE]

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