A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P)
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|ClinicalTrials.gov Identifier: NCT01784913|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2013
Last Update Posted : April 4, 2017
In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
Main treatment period is completed and reported. Follow-up ongoing.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: UV1 synthetic peptide vaccine and GM-CSF||Phase 1 Phase 2|
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:
- Conventional dose escalation with at least 3 patients per dose level (3 selected dose levels).
- Expansion of each dose level to a total of 7 patients for assessment of immune response levels
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIA Study of UV1 Vaccination in Patients With Hormone-sensitive Metastatic Prostate Cancer|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: UV1 synthetic peptide vaccine and GM-CSF
GM-CSF (Leukine) followed by UV1 peptide vaccine with escalating concentrations (100, 300 and 700 microgram) will be injected intradermally at the same injection in the lower abdomen.
Biological: UV1 synthetic peptide vaccine and GM-CSF
- Assessment of safety and tolerability of UV1 [ Time Frame: up to 9 months ]Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.
- Immunological response [ Time Frame: Up to 9 months ]Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response.
- Selection of biological dose of peptides for further clinical trials [ Time Frame: up to 9 months ]Safety profile and immunological responses of each dose level.
- Assessment of anti tumor activity; (sPSA measurements and multiparametric radiological assessments). [ Time Frame: Up to 6 months ]Tumor response, progression free survival (PFS), and changes in antineoplastic treatment
- Potential correlation between human cytomegalovirus status and immune response. [ Time Frame: Up to 9 months ]Determination of human cytomegalovirus (CMV) status
- Further characterization of the immune reaction triggered by the treatment. [ Time Frame: Up to 6 months ]T-cell infiltration of the prostatic gland after 6 months and compared to the initial multiparametric MRI.
- Identification of prognostic surrogate markers. [ Time Frame: Up to 6 months ]
Genetic analyses (DNA), gene expression profiling (RNA), proteomics, metabolomics from samples (blood, urine, tissue) collected at Baseline and repeated after 6 months (blood, urine).
Circulating tumor cells will be measured at baseline and month 6.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784913
|Oslo University Hospital|
|Oslo, Norway, 0424|
|Principal Investigator:||Wolfgang Lilleby, MD PhD||Oslo University Hospital|