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    Summary
    EudraCT Number:2019-001083-30
    Sponsor's Protocol Code Number:VIGAS2
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-25
    Trial 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 ConcernedNorway - NOMA
    A.2EudraCT number2019-001083-30
    A.3Full title of the trial
    A multicenter randomized double-blinded controlled
    phase 2 study evaluating the efficacy of valganciclovir as
    add-on therapy in glioblastoma patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the effect of the anti-viral drug Valganciclovir in brain tumor patients
    A.4.1Sponsor's protocol code numberVIGAS2
    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 SponsorKarolinska Institutet
    B.1.3.4CountrySweden
    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 supportKarolinska Instituet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital; SLL
    B.5.2Functional name of contact pointKonstantinos Kostulas
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska Universitetssjukhuset Hotellet plan 4
    B.5.3.2Town/ citySolna
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number+46725957237
    B.5.6E-mailkonstantinos.kostulas@sll.se
    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 Yes
    D.2.1.1.1Trade name valganciclovir Valcyte
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namevalganciclovir
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma is an incurable brain tumor with very dismal prognosis. Substantial evidence demonstrates that cytomegalovirus (CMV) is present in 90-100% of malignant glioblastoma. We have observed that valganciclovir is well tolerated among glioblastoma patients receiving temozolomide and radiation therapy. We further observed that treatment with valganciclovir may enhance the survival chances for glioblastoma patients. We aim to assess the efficacy of Valganciclovir in glioblastoma patients.
    E.1.1.1Medical condition in easily understood language
    Brain tumor glioblastoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy.
    E.2.2Secondary objectives of the trial
    Secondary objectives include comparison of different survival and toxicity parameters in patients with newly-diagnosed glioblastoma treated with and without valganciclovir as add-on to standard therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged 18 years or older
    2. Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV
    3. Patients were a radical tumor resection has been achieved; no more than 1 cm3 remaining contrast enhancing tumor as assessed by postoperative MRI or CT is allowed.
    4. Patients eligible for standard treatment with radiation therapy combined with concomitant and adjuvant
    5. MGMT promoter methylation status
    6. Patients with at least KPS 70 , ECOG/WHO 2
    7. Patients providing written informed consent
    8. Patients cooperative and able to complete all the assessment procedures.
    9. Females of child-bearing age must have a negative pregnancy test at screening (all premenopausal women and in women under the age of 55 were menstrual status cannot be ascertained). Female patients must agree to utilize a highly efficient birth control method throughout the study period (Pearl index <1, e.g: oral contraception with gestagens, transdermal contraceptives, implants, injectables, intrauterine devices, bilateral tubal occlusion, sexual abstinence or vasectomised partner). The birth control method must be used until 6 months after last dose of study drug. Pregnancy testing will be performed at monthly intervals due to high teratogenic potential of valganciclovir, and continue for 6 months after the Study drug has been discontinued. Men are recommended to use condoms with female fertile partners during, and for 6 months following treatment with valganciclovir.
    10. Patients must be enrolled within 10 weeks after surgery
    E.4Principal exclusion criteria
    1. Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment
    2. Patients intolerant to ingredients of the study drug tablets
    3. Patients with decreased cognitive function (score below 24 in MMSE test)
    4. Pregnant or lactating females
    5. Patients not signing informed consent
    6. Patient participating in other interventional trials
    7. Neutrophil count < 1500 cells/mm3l
    8. Platelet count < 150 000 cells/ mm3
    8. HGB < 8g/dL
    10. Abnormal renal function (GFR < 30)
    11. Secondary glioblastoma, or glioblastoma IDH mutated.
    12. Unfit for any other reason judged ineligible by investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is median OS at EoS when the last patient has completed 30 months follow up time. OS time is measured from time of resection until death for any reason. The study code will be broken when the last patient has passed 30 months, an SAP is signed, the eCRF is fully registered and cleaned, and the database locked.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months follow up time after inclusion.
    E.5.2Secondary end point(s)
    • One (12 months) and two year (24 months) survival rates Median progression free survival time; time from resection to objective demonstration of disease progression or death (PFS), whichever occurs first
    • Quality of life assessments as assessed by EORTC QLQ C30 and BN20 questionnaires at base line and at 3, 6, 9, 12, 15, 18, 21, 24 and 30 months
    • Proportion of patients with progressive disease at 12 and 24 months
    • Proportion of patients with stable disease at 12 and 24 months
    • Subgroup analyses will be performed of treatment response according to CMV status (grade of infection or serostatus versus median OS, one and two year survival rates, and PFS time)
    • Subgroup analysis for patients receiving Optune treatment (median OS, one and two year survival rates, and PFS time)
    • Subgroup analysis for patients needing surgical interventions during the first 24 months (median OS, one and two year survival rates, and PFS time)
    Evaluation of safety and tolerance for valganciclovir as add-on to standard therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor volume/ disease status assessments at 12 and 24 months, Quality of life assessments at:3, 6, 9, 12, 15, 18, 21, 24 and 30 months.
    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 Yes
    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 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    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
    The study will be ongoing until the last patient has completed the 30 months follow up visit (End of Study).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 220
    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)
    Glioblastoma is a severe diagnosis and patients are followed for life by their respective clinic for patient care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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