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    Summary
    EudraCT Number:2019-000951-14
    Sponsor's Protocol Code Number:RhoVac-002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2019-000951-14
    A.3Full title of the trial
    A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate Cancer
    et dobbeltblindt, placebokontrolleret fase 2-forsøg med anvendelse af RV001V til mænd med biokemisk insufficiens efter kurativ intenderet behandling af lokaliseret prostatakræft
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess effectiveness and safety of a drug RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate Cancer
    A.3.2Name or abbreviated title of the trial where available
    BRaVac
    A.4.1Sponsor's protocol code numberRhoVac-002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRhoVac ApS
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRhoVac ApS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRhoVac ApS
    B.5.2Functional name of contact pointMalene Weis
    B.5.3 Address:
    B.5.3.1Street AddressSCION DTU Science Park Agern Alle 24
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post codeDK-2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4553542818
    B.5.6E-mailmw@rhovac.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRV001 Vaccine 0.1 mg/mL
    D.3.2Product code RV001V
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRV001 (INN not yet assigned)
    D.3.9.2Current sponsor codeRV001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEmulsion for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007113
    E.1.2Term Cancer of prostate
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate whether a vaccination regimen with multiple subcutaneous (SC) administrations of RV001 Vaccine 0.1 mg/mL (RV001V) can reduce prostate-specific antigen (PSA) progression compared to the control group.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the safety and tolerability of RV001 Vaccine 0.1 mg/mL (RV001V) following SC administrations to patients who have a biochemical relapse following definitive local therapy prostatectomy or radiation therapy due to prostate cancer.
    - To evaluate whether the vaccination regimen can delay the time to subsequent antineoplastic therapy initiation and substantiate other clinical benefits compared to the control group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men aged 18 and above with an earlier histologic diagnosis of prostatic adenocarcinoma.
    2) Able to understand the study procedures and willing to provide IC.
    3) Able and willing to comply with study requirements and complete all visits.
    4) Biochemical recurrence (BCR) in compliance with the following 3 conditions: after having finished last definitive treatment (incl. those who have received RP/RT followed by any modality of salvage ther.); no distant metastasis by standard CT imaging with bone scintigraphy or a normal PET-CT; and no locoregional recurrence (including lymph nodes). Locoregional recurrence will be assessed by multi-parametric magnetic resonance imaging (MRI) in all patients treated with curative RT and should be confirmed with image guided prostatic gland biopsy in case of suspicious lesions. Any prostatic biopsy performed should be negative.
    5) Prior definitive treatm. with RP or RT. In case the pt. was subj. to a RP, all the following will apply:
    a. PSA ≥0.2 ng/mL,
    b. PSA Doubling Time (PSADT)a >3 months and <12 months,
    c. History of Gleason 7 (4 + 3) or higher.
    Conversely, if the patient was treated with definitive RT and not prior RP, all of the following criteria will apply:
    a. PSA >nadir + 2 ng/mL,
    b. PSADTa >3 months and <12 months,
    c. History of Gleason score of 7 (4 + 3) or higher.
    6) Eastern Cooperative Oncology (ECOG) performance status ≤2.
    7) Laboratory values obtained ≤30 days prior to first vaccination:
    a. Hemoglobin ≥5.6 mmol/L(0.72 g/L)
    b. Absolute granulocyte count ≥1.5 x 109 /L.
    c. Platelets ≥100 x 109 /L.
    d. Total bilirubin ≤1.5 x upper limit of normal (ULN).
    e. Creatinine ≤1.5 x ULN.
    f. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline
    phosphatase (ALP) ≤2.5 x ULN.
    E.4Principal exclusion criteria
    1) Patients who are receiving androgen-deprivation therapy (ADT) or considered a candidate for immediate ADT or are candidate to any local therapy according to applicable clinical guidelines or judged by the investigator
    2) Patients who have received prior ADT are not eligible with the exception of those that received ADT ≤36 months in duration and ≥9 months before randomization and administered only in the neoadjuvant/adjuvant setting.
    3) Patient is planned for salvage therapy.
    4) Castrate level of serum testosterone <50 ng/dL at screening.
    5) PSA >10 ng/mL.
    6) Small-cell, signet cell and neuroendocrine variants of adenocarcinomas.
    7) An active malignancy likely to interfere with protocol treatment or FU.
    8) Patients who have undergone major surgery or have had major bleeding within the last month prior to the first vaccination.
    9) Prior treatment with any therapeutic cancer vaccine(s).
    10) Participants with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily
    rednisone equivalent, are permitted in the absence of active autoimmune disease.
    11) History of alcohol or substance abuse within the last 5 years.
    12) Patients receiving any investigational drug(s) or treatment within 30 days prior to inclusion in this trial.
    13) History of significant autoimmune disease such as Inflammatory Bowel Disease, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Scleroderma, Multiple Sclerosis.
    14) Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.
    15) Other medications, conditions or laboratory results that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.
    16) History of known allergy/hypersensitivity to any of the component of the study drug (such as Montanide ISA 51), or intolerance to SC injection.
    17) Patients with a prior solid organ/stem cell transplantation
    18) Patients with known acquired immunodeficiency disorder (AIDS) or any inherited immunodeficiency disorder
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the time to PSA progression is defined as the time from randomization to doubling of PSA from the baseline value. The time to doubling will be estimated from a log-linear regression of PSA values. Estimated time to doubling will be calculated as 1/β where β is the slope of the log-linear regression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end-of-treatment is within 30 days after the final dose of study treatment. Follow-up visits will begin 12 weeks after end-of-treatment visit, and then every 12 weeks until the patient reaches primary
    endpoint, or until primary analysis. When the patient reaches a primary endpoint he will move into extended follow up for safety monitoring until the study is terminated 36 months after first patient's first injection.
    E.5.2Secondary end point(s)
    - The safety will be evaluated with frequency and severity of adverse events (AEs). The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized. Immune-related AEs (irAEs) will be reported, evaluated and managed following the procedure detailed in sect. 9. Safety monitoring and review
    - Time to initiation of a subsequent antineoplastic therapy.
    - Proportion of patients initiating a subsequent antineoplastic therapy.
    - PSA doubling time (PSADT) based on uncensored data.
    - Proportion of patients showing a PSA response from baseline (50% and
    30%, best and at 26 weeks):
    a. 50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA) at 26 weeks (Visit 12) after baseline.
    b. 30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA) at 26 weeks (Visit 12) after baseline.
    c. Best PSA response is defined as the proportion of patients who have at least a 30% or 50% decrease in PSA level (compared to baseline PSA) at any time point postrandomization.
    - Disease-free survival (DFS) is defined as time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end-of-treatment is within 30 days after the final dose of study treatment. Follow-up visits will begin 12 weeks after end-of-treatment visit, and then every 12 weeks until the patient reaches primary
    endpoint, or until primary analysis. When the patient reaches a primary endpoint he will move into extended follow up for safety monitoring until the study is terminated 36 months after first patient's first injection.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-02
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