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

NCT01784913 | Completed Phase 1 DMC

• 1 other identifier: 2012-002411-26
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Prostate; cancer; vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• Immunological response

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

  Up to 9 months

Secondary Outcomes (1)

• Selection of biological dose of peptides for further clinical trials

  up to 9 months

Other Outcomes (4)

• Assessment of anti tumor activity; (sPSA measurements and multiparametric radiological assessments).

  Up to 6 months

• Potential correlation between human cytomegalovirus status and immune response.

  Up to 9 months

• Further characterization of the immune reaction triggered by the treatment.

  Up to 6 months

Study Arms (1)

UV1 synthetic peptide vaccine and GM-CSF

EXPERIMENTAL

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

Interventions

UV1 synthetic peptide vaccine and GM-CSF BIOLOGICAL

Also known as: UV1, Leukine

UV1 synthetic peptide vaccine and GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to CAB (GnRH-agonist combined with anti-androgen)
• 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
• 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

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Ultimovacs ASA: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 36715014 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Wolfgang Lilleby, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 6, 2013
• Study Start: April 15, 2013
• Primary Completion: July 8, 2015
• Study Completion: October 23, 2020
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

NO (1)