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Prostate CancerPhase 1/2UV1/hTERT2012PNCT01784913

A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer

A Phase 1/2 study testing UV1 synthetic peptide vaccine and GM-CSF in people with Prostate Cancer, run by Ultimovacs ASA at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
UV1 synthetic peptide vaccine and GM-CSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteNorway
Study dates
15 Apr 2013to 23 Oct 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to CAB (GnRH-agonist combined with anti-androgen)
  • Patients already on GnRH-agonist must have a history sPSA < 200 ng/mL prior to start of GnRH-agonist treatment. GnRH-agonist with or without bicalutamide can have been initiated up to 6 months prior inclusion.
  • Must be ambulatory with an ECOG performance status of 0 or 1 and not have contraindications for MRI (pacemaker, claustrophobia, metal splints).
  • Must be at least 18 years of age.
  • Must have lab values as follows:
  • White Blood Cells ≥ 1.5 x 109/L
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  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9g/dL (≥ 5.6 mmol/L)
  • Creatinine ≤ 140 µmol/L; if creatinine is borderline, the creatinine clearance ≥ 40 mL/min;
  • Bilirubin < 20% above the upper limit of normal
  • ASAT and ALAT ≤ 1.5 the upper limit of normal
  • Albumin ≥ 2.5 g/L
  • Normal NSE
  • sPSA < 200 ng/mL.
  • Signed informed consent

Who cannot join

  • History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
  • Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug.
  • Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
  • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome.
  • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
  • Active infection requiring antibiotic therapy.
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  • Known hypersensitivity to any of the components of the vaccine
  • Known hypersensitivity to Leukine®, yeast derived products or any component of the product
  • Patients who test positive for hepatitis B, C or HIV
  • Any other anti-tumor treatment (including chemotherapy, immunotherapy, cytokines, interferons, protease inhibitors and gene therapy) administered with the exception of GnRH-agonist with or without bicalutamide started up to 6 months prior inclusion.
  • Use of not permitted concomitant medication:
  • chronic corticosteroids except for asthma inhalers / topical use
  • any agent with a known effect on the immune system, unless it is being given at dose levels that are not immunesuppressive, e.g. prednisone at 10mg/day or less
  • any alternative and complementary drugs that may affect the immune system or be potentially harmful to patients participating in phase I studies.
  • Any reason why, in the opinion of the investigator, the patient should not participate.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, 0424

Other trials in Norway

About this study

Official title: A Phase I/IIA Study of UV1 Vaccination in Patients With Hormone-sensitive Metastatic Prostate Cancer

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.

Read the detailed description

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 levels).
  2. 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.

Conditions
Prostate Cancer
Being tested
UV1 synthetic peptide vaccine and GM-CSF
Keywords
Prostate, cancer, vaccine
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UV1 synthetic peptide vaccine and GM-CSFBiological

    Also called UV1, Leukine

Study groups in NCT01784913
Study groupRoleWhat they receive
UV1 synthetic peptide vaccine and GM-CSFExperimentalGM-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.
Receives: Biological: UV1 synthetic peptide vaccine and GM-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 9 months

  2. Immunological response

    Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response.

    Measured: Up to 9 months

Secondary outcomes (1)

  1. Selection of biological dose of peptides for further clinical trials

    Safety profile and immunological responses of each dose level.

    Measured: up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2013 (estimated)
  2. Study start15 Apr 2013
  3. Primary completion8 Jul 2015
  4. Study completion23 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01784913
Sponsor's protocol ID
2012-002411-26
Acronym
UV1/hTERT2012P
Status last verified
Dec 2024
First submitted
23 Jan 2013
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Lilleby W, Seierstad T, Inderberg EM, Hole KH. Impact of human telomerase reverse transcriptase peptide vaccine combined with androgen deprivation therapy and radiotherapy in de novo metastatic prostate cancer: Long-term clinical monitoring. Int J Cancer. 2023 May 15;152(10):2166-2173. doi: 10.1002/ijc.34448. Epub 2023 Feb 4.

    PubMed 36715014

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing UV1 synthetic peptide vaccine and GM-CSF in people with Prostate Cancer, run by Ultimovacs ASA at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of safety and tolerability of UV1 (time frame: up to 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01784913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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