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    Summary
    EudraCT Number:2013-002663-25
    Sponsor's Protocol Code Number:VEGFVAX
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002663-25
    A.3Full title of the trial
    A phase I- IIa open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors
    Een fase I-IIa klinische studie naar het therapeutisch vaccin hVEGF26-104/RFASE in patienten met een gemetastaseerde solide tumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I-IIa clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced cancer
    Een fase 1-IIa studie naar het vaccin hVEGF26-104/RFASE bij patiënten met een uitgezaaide vorm van kanker.
    A.4.1Sponsor's protocol code numberVEGFVAX
    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 SponsorVU University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImmunovo BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointSecretary Medical Oncology
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310204444321
    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 namehVEGF26-104
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhVEGF26-104
    D.3.9.2Current sponsor codehVEGF26-104
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) No
    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.IMP: 2
    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 nameRFASE
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRFASE
    D.3.9.2Current sponsor codeRFASE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced solid tumors
    Gemetastaseerde solide tumoren
    E.1.1.1Medical condition in easily understood language
    Advanced cancer
    Uitgezaaide vorm van kanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    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
    Part 1:
    The primary objectives of the study are:
    - To investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE.
    - To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0 pg/mL.

    Part 2:
    - To investigate the safety and VEGF neutralizing ability of hVEGF26-104/RFASE combined with irinotecan chemotherapy in a metastatic colorectal cancer expansion cohort.
    - To investigate the safety and VEGF neutralizing ability of hVEGF26-104/RFASE combined with the XELOX regimen (capecitabine plus oxaliplatin) in a metastatic colorectal cancer expansion cohort.
    Deel 1:
    - Het onderzoeken van de veiligheid en verdraagzaamheid van het therapeutische vaccin hVEGF26-104/RFASE.
    - Het bepalen van de effectieve dosis van hVEGF26-104/RFASE die nodig is om VEGF te neutraliseren in serum, gedefinieerd als een VEGF concentratie lager dan 9.0 pg/mL.

    Deel 2:
    - Het onderzoeken van de veiligheid, verdraagzaamheid en VEGF neutraliserende capaciteit van hVEGF26-104/RFASE wanneer het gecombineerd wordt met irinotecan chemotherapie in een gemetastaseerd colorectaal carcinoom uitbreidingscohort.
    - Het onderzoeken van de veiligheid, verdraagzaamheid en VEGF neutraliserende capaciteit van hVEGF26-104/RFASE wanneer het gecombineerd wordt met XELOX (capecitabine plus oxaliplatin) chemotherapie in een gemetastaseerd colorectaal carcinoom uitbreidingscohort.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to investigate:
    - The anti-VEGF antibody titer, induced by hVEGF26-104/RFASE administration.
    - To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in plasma and in a platelet sample.
    - The effect of VEGF neutralization in a functional Ba/F3-R2 cell proliferation assay.

    The exploratory objectives of the study are:
    - To assess the cellular anti-tumor immune response upon hVEGF26-104/RFASE administration.
    - To assess immunomodulatory effects upon hVEGF26-104/RFASE administration.
    - To make a preliminary assessment of hVEGF26-104/RFASE to suppress angiogenesis within the tumor.
    - To assess the immune infiltration and the regulation of endothelial cell adhesion molecules in the tumor.
    Secundair:
    - De anti-VEGF antilichaam titer, geinduceerd door vaccinatie met hVEGF26-104/RFASE.
    - Het bepalen van de effectieve dosis van hVEGF26-104/RFASE die nodig is om VEGF te neutraliseren in plasma en trombocyten sample.
    - Het onderzoeken van het effect van VEGF neutralisatie in een een functionele Ba/F3-R2 cel proliferatie assay.

    Exploratoir:
    - Het onderzoeken van de cellulaire anti-tumor respons na hVEGF26-104/RFASE vaccinatie.
    - Onderzoeken van immunomodulatoire effecten na hVEGF26-104/RFASE vaccinatie.
    - Beoordelen van de capaciteit van hVEGF26-104 vaccinatie om angiogenese in de tumor te remmen.
    - Beoordelen van immuuninfiltratie en de regulatie van endotheelcel adhesiemoleculen in de tumor na hVEGF26-104/RFASE vaccinatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed advanced, solid malignancy.
    - Refractory or not amenable to standard therapy
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    - Willing and able to give written informed consent
    - Patient is ≥ 18 years of age at the time of signature of the informed consent
    - Adequate hematological function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, Hemoglobin ≥ 6.0 mmol/L.
    - Adequate hepatic function: serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST ≤ 2.5 x ULN (or ≤ 5 times ULN if liver metastases are present).
    - Adequate renal function: eGFR ≥ 50ml/min
    - Female patients of childbearing potential may be enrolled in the study, if the patient
    o Has practiced adequate contraception for 30 days prior to first hVEGF26-104/RFASE administration.
    o Negative pregnancy test
    o Has agreed to continue adequate contraception for as long as VEGF is neutralized.
    - Part 2 only:
    o Histological confirmed advanced colorectal cancer
    o Planning to initiate treatment with irinotecan or
    o Planning to initiate second line treatment with the XELOX regimen after progression on first line treatment with XELOX combined with bevacizumab.
    1. Histologsich aangetoonde gemetastaseerde solide tumor
    2. Reageert niet (meer) of is niet geschikt voor standaard therapie
    3. ECOG status 0 of 1
    4. Wil en is in staat om toestemmingsformulier te tekenen
    5. Is 18 jaar of ouder op het moment van het tekenen van het toestemmingsformulier
    6. Adequate hematologische functie: ANC ≥ 1.5 x 109/L, thrombocyten ≥ 100 x 109/L, Hemoglobine ≥ 6.0 mmol/L.
    7. Adequate leverfunctie: serum bilirubine ≤ 1.5 x de bovengrens van normaal, ALT and AST ≤ 2.5 x de bovengrens van normaal (or ≤ 5 x de bovengrens van normaal als er levermetastasen aanwezig zijn).
    8. Adequate nierfunctie: eGFR ≥ 50ml/min
    9. Vrouwelijke patienten in de vruchtbare periode van hun leven mogen meedoen aan de studie als:
    - Adequate anticonceptie gebruiken tenminste 30 dagen voor de eerste behandeling met hVEGF26-104/RFASE.
    - Een negatieve zwangerschapstest hebben
    10. Alleen deel 2:
    - Histologisch bevestigd gemetastaseerd colorectaal carcinoom
    - Planning om te starten met irinotecan behandeling
    - Planning om te starten met tweedelijns behandeling met het XELOX regime na progressie op eerstelijns behandeling met XELOX + bevacizumab
    E.4Principal exclusion criteria
    - Major surgery within 28 days before the initiation of study treatment
    - Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment.
    - Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment.
    - Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
    - The patient is scheduled to receive another vaccination during the DLT period.
    - A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis.
    - Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment.
    - Primary or secondary immunodeficiency
    - Treatment with a glucocorticoid derivative in an equivalent dose of ≥ 10mg prednisone a day.
    - Female patients: the patient is pregnant or lactating.
    - Part 1 only:
    o When the patient is scheduled to receive any other anticancer treatments than those specified in the protocol.
    o Chemotherapy within 28 days prior to the initiation of study treatment.
    1. Grote operatie binnen 28 dagen voor start van de studiebehandeling
    2. Ernstige niet-helende wonden, ulcera of botfracturen binnen 28 dagen voor start van de studiebehandeling
    3. Diep veneuze trombose (DVT) of longembolie binnen 1 jaar voor start van de studiebehandeling.
    4. Hypertensie (systolisch > 150 mmHg en/of diastolisch > 100 mmHg) die niet reageert op behandeling
    5. Er is een andere vaccinatie gepland tijdens de DLT periode
    6. Een eerdere serieuze allergische reactie na vaccinatie zoals angio-oedeem en anafylaxie.
    7. Behandeling met bevacizumab binnen 6 weken voor start van de studiebehandeling
    8. Auto-immuunziekten die niet reageren op behandeling
    9. Primaire of secundaire immunodeficientie, inclusief HIV
    10. Behandeling met een glucocorticoid derivaat in een dosis die equivalent is aan een prednison dosis van ≥ 10 mg/dag.
    11. Vrouwelijke patienten: de patiente is zwanger of geeft borstvoeding
    12. Alleen deel 1:
    - Er is een andere anti-kanker behandeling gepland dan die gespecificeerd staan in het protocol
    - Chemotherapie binnen 28 dagen voor start van de studiebehandeling
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    1. Safety and tolerability of hVEGF26-104/RFASE.
    2. Neutralization of endogenous VEGF in serum, defined as a VEGF level below 9,0 pg/mL as determined by sandwich ELISA.

    Part 2:
    1. Safety and tolerability of hVEGF26-104/RFASE in combination with different chemotherapy regimens.
    2. Neutralization of endogenous VEGF in serum, defined as a VEGF level below 9,0 pg/mL as determined by sandwich ELISA.
    Deel 1:
    - Veiligheid en verdraagzaamheid van hVEGF26-104/RFASE
    - Neutralisatie van endogeen VEGF in serum, gedefinieerd als een VEGF concentratie lager dan 9.0 pg/mL gemeten met sandwich ELISA.

    Deel 2:
    1. Veiligheid en verdraagzaamheid van hVEGF26-104/RFASE in combinatie met verschillende chemotherapie regimens.
    2. Neutralisatie van endogeen VEGF in serum, gedefinieerd als een VEGF concentratie lager dan 9.0 pg/mL gemeten in een sandwich ELISA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Safety and tolerability will be assessed at each treatment visit. The DLT period is defined as 10 weeks.
    2. VEGF concentration in serum will be assessed at each treatment visit.
    1. Veiligheid en verdraagzaamheid wordt bij elk onderzoeksbezoek beoordeeld. De DLT periode is gedefinieerd als 10 weken.
    2. VEGF concentratie in serum zal na elk onderzoeksbezoek worden bepaald.
    E.5.2Secondary end point(s)
    Part 1:
    Secondary end points
    1. Anti-VEGF antibody titer in serum, plasma and a platelet sample, as determined by indirect ELISA. 2. VEGF concentration in plasma as determined by sandwich ELISA.
    3. VEGF concentration in a platelet sample as determined by sandwich ELISA.
    4. Functional VEGF neutralization, as determined in a Ba/F3-R2-R2 cell proliferation bio-assay.

    Exploratory end points
    1. Cellular (T-cell) immune response, as determined by ELISPOT
    2. Immune modulation
    3. Angiogenesis suppression within the tumor, by assessing microvessel density (MVD), quantity of proliferating endothelial cells and pericyt coverage.

    Deel 1:
    Secundaire eindpunten
    1. Anti-VEGF antilichaam titer in serum, plasma en een trombocyten sample, bepaald met een indirecte ELISA techniek.
    2. VEGF concentratie in plasma gemeten met sandwich ELISA.
    3. VEGF concentratie in een trombocyten sample, gemeten met sandwich ELISA.
    4. Functionele VEGF neutralisatie, bepaald in een Ba/F3-R2 cel proliferatie bio-assay.

    Exploratoire eindpunten
    1. Cellulaire (T-cel) immuun respons, bepaald met ELISPOT.
    2. Immunomodulatie
    3. Angiogenese onderdrukking, door het beoordelen van de microvaatdichtheid (MVD), aantal proliferende endotheelcellen en pericyt bedekking.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points
    1. Will be assessed at each treatment visit
    2. Will be assessed at each treatment visit
    3. Will be assessed at each treatment visit
    4. Will be assessed at each treatment visit

    Exploratory end points
    1. Will be assessed at day 0, week 4, week 10 and week 26
    2. Will be assessed at day 0, week 10, week 10 and week 26
    3. Will be assessed at day 0 and week 10
    Secundaire eindpunten
    1. Zal bij elk onderzoeksbezoek onderzocht worden.
    2. Zal bij elk onderzoeksbezoek onderzocht worden.
    3. Zal bij elk onderzoeksbezoek onderzocht worden.
    4. Zal bij elk onderzoeksbezoek onderzocht worden.

    Exploratoire eindpunten
    1. Zal op dag 0, week 4, week 10 en week 26 van de studie onderzocht worden.
    2. Zal op dag 0, week 4, week 10 en week 26 van de studie onderzocht worden.
    3. Zal op dag 0 en week 10 van de studie onderzocht worden.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other 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.8.5The trial involves multiple Member States No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state35
    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)
    Following discontinuation of the IMP, standard care will restarted (usually palliative care). Costs for continuing care will be the responsibility of the patient’s healthcare insurance company (or patient).
    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 Decision2013-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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