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    Summary
    EudraCT Number:2019-002264-27
    Sponsor's Protocol Code Number:ENGOT-ov54/Swiss-GO-2/MATAO
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-002264-27
    A.3Full title of the trial
    MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer: a randomized double-blinded placebo-controlled multi-center phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO) including LOGOS (LOw Grade Ovarian cancer Sub-study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer
    A.3.2Name or abbreviated title of the trial where available
    MATAO
    A.4.1Sponsor's protocol code numberENGOT-ov54/Swiss-GO-2/MATAO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04111978
    A.5.4Other Identifiers
    Name:AGONumber:AGO-OVAR 26
    Name:ENGOTNumber:ENGOT-ov54
    Name:Swiss-GONumber:Swiss-GO-2
    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 SponsorSwiss GO Trial Group
    B.1.3.4CountrySwitzerland
    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 supportSwiss GO Trial Group
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportKrebsliga Schweiz, Anticancer Fund (Reliabel Cancer Therapies)
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportStiftung Fürstlicher Kommerzienrat Guido Feger (Krebsliga Lichtenstein)
    B.4.2CountryLiechtenstein
    B.4.1Name of organisation providing supportHelsana Versicherung
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche AG
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportArbeitsgemeinschaft Gynäkologische Onkologie e.V.
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportNovartis
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGO Research GmbH
    B.5.2Functional name of contact pointFriederike Kipkeew
    B.5.3 Address:
    B.5.3.1Street AddressMoltkeplatz 63
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45138
    B.5.3.4CountryGermany
    B.5.4Telephone number004920195981214
    B.5.5Fax number004920195981221
    B.5.6E-mailoffice-essen@ago-ovar.de
    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 Femara
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFemara
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number2,5
    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 placeboFilm-coated tablet
    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
    Patients with low and high grade serous and endometrioid ovarian cancer patients.
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 in this study is to evaluate the efficacy of letrozole maintenance therapy after standard surgical and chemotherapy treatment as measured by Progression Free Survival (PFS) compared to no maintenance therapy (placebo) in patients with newly diagnosed ER positive epithelial ovarian cancer(histologic subtype: serous or endometrioid of low/high grade, including fallopian tube and primary peritoneal
    cancer) of FIGO Stage II-IV, with or without residual disease and with or without concomitant anti-VEGF and/or PARPi medication, whose cancer has not progressed by the end of adjuvant chemotherapy treatment.
    E.2.2Secondary objectives of the trial
    To determine the impact of letrozole maintenance
    compared to placebo after primary treatment in ER positive advanced stage ovarian/ tubal/ peritoneal cancer patients on Overall Survival (OS), Quality Adjusted Progression Free Survival (QAPFS), Time to First Subsequent Treatment (TFST), Quality adjusted Time Without Symptoms of disease and Toxicity (Q-TWiST) and Health Related Quality of Life (QoL) assessed via specific questionnaires.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Patients must be ≥18 years of age
    · Willing and able to attend the visits and to understand all study-related
    procedures.
    · Primary, newly diagnosed FIGO Stage II to IV and histologically
    confirmed low or high grade serous or endometrioid epithelial
    ovarian/fallopian tube/peritoneal cancer
    · (Interval-) debulking performed
    · ECOG-Performance Status 0-2
    · Signed informed consents (ICF-1; ICF-2)
    · Paraffin-embedded tissue or paraffin-embedded cell block (from ascites)
    available
    · Positivity (≥ 1%) for ER expression (only determined by Histopathology
    Core Facility of MATAO trial)
    · At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
    · Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.
    E.4Principal exclusion criteria
    • Progressive disease at the end of adjuvant treatment
    • Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
    • Pregnant or lactating women
    • Any other malignancy within the last 5 years which has impact on the prognosis of the patient
    • < 4 cycles of chemotherapy in total
    • Contraindications to endocrine therapy
    • Inability or unwillingness to swallow tablets
    • Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose mal-absorption
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years after study start
    E.5.2Secondary end point(s)
    Overall Survival (OS), defined for each patient as the time from randomization until the date of death from any cause. Patients not having an event at the time of analysis will be censored at the date they were last known to be alive.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 5 years of study start
    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 No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Switzerland
    Austria
    Germany
    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 years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 540
    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)
    Standard of 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 Decision2022-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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