E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to Complete Androgen Blockade therapy (GnRH-agonist combined with anti-androgen). |
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E.1.1.1 | Medical condition in easily understood language |
Patients with metastatic prostate cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071119 |
E.1.2 | Term | Hormone-dependent prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Immunological response to UV1 vaccine and assessment of safety and tolerability of UV1. |
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E.2.2 | Secondary objectives of the trial |
Selection of biological dose of peptides for further clinical trials and assessment.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
As a sub-study, we will obtain” fluid biopsies” (urine, blood) and if possible tissue samples ascertaining insight in tumor biology. Characterization of this material may support future study design and evaluation of our peptide vaccine.
Blood and urine samples will be collected prior and after the 6 months vaccination period. Tissue sample will be collected prior start of vaccination.
Participation in this sub-study is optional for the patients and specific consent is being collected. |
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E.3 | Principal inclusion criteria |
• Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to Complete Androgen Blockade (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
• 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
- 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
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E.4 | Principal exclusion criteria |
• History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB 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 sensitivity 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 alternative and complementary drugs.
• Any reason why, in the opinion of the investigator, the patient should not participate.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Frequency and severity of adverse events and serious adverse events. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) will be used.
Changes in laboratory values, vital signs and ECOG performance status will also be assessed.
- Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Safety profile will be evaluated at each visit. Patient will come during week 1, 2, 3, 4, 6, 8, 10, every 4 weeks until week 26. FU will be done at 3 months post vaccination.
-T cell response will be measured at baseline, during vaccination (every 4 weeks starting at week 2), end of treatment and at the end of the 3 months follow up period. |
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E.5.2 | Secondary end point(s) |
- Safety profile and immunological responses of each dose level.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Safety profile and immunological responses of each dose level will be evaluated when patients have completed 6 months of vaccinations and have been followed up for at least a further 3 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Visit of the Last Subject (LVLS).
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |