A Phase I/IIA Study of UV1 Vaccination in Patients With Hormone-sensitive Metastatic Prostate Cancer
The study is an open labeled dose-escalating phase I/IIa study of UV1 peptide vaccination in
patients with androgen-sensitive metastatic prostate cancer. Patients will be prospectively
enrolled in this study if diagnosis of adenocarcinoma only has been histologically confirmed
and they are eligible for (or have already started up to 6 months prior to inclusion)
standard GnRH-agonist first line androgen deprivation therapy (ADT) combined with
anti-androgen to achieve complete androgen blockade (CAB). UV1 vaccinations will be applied
simultaneously with CAB.
When indicated, patients may receive concomitant radiotherapy.
The following 2-step design will be used:
1. Conventional dose escalation with at least 3 patients per dose level (3 selected dose
2. Expansion of each dose level to a total of 7 patients for assessment of immune response
13 UV1 vaccinations will be given during the first 6 months (week 26) of treatment, unless
clinical deterioration or unacceptable toxicity is encountered. GM-CSF (Leukine ®) will be
administered locally 10-15 minutes before each UV1 vaccination.
Hormone naïve patients will receive standard complete androgen blockade by GnRH-agonist (3
months depot formulation sc.) and bicalutamide 50 mg orally per day (CAB). Patients already
on GnRH-agonist therapy will continue with their initial treatment with addition of
bicalutamide 50 mg orally per day.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of safety and tolerability of UV1
Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.
up to 9 months
Wolfgang Lilleby, MD PhD
Oslo University Hospital
Norway: Norwegian Medicines Agency